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The International Energy Outlook 2013 (IEO2013) projects that world energy consumption will grow by 56 percent between 2010 and 2040. Total world energy use rises from 524 quadrillion British thermal units (Btu) in 2010 to 630 quadrillion Btu in 2020 and to 820 quadrillion Btu in 2040 (Figure 1). Much of the growth in energy consumption occurs in countries outside the Organization for Economic Cooperation and Development (OECD),2 known as non-OECD, where demand is driven by strong, long-term economic growth. Energy use in non-OECD countries increases by 90 percent; in OECD countries, the increase is 17 percent. The IEO2013 Reference case does not incorporate prospective legislation or policies that might affect energy markets.
Renewable energy and nuclear power are the world's fastest-growing energy sources, each increasing by 2.5 percent per year. However, fossil fuels continue to supply almost 80 percent of world energy use through 2040. Natural gas is the fastest-growing fossil fuel in the outlook. Global natural gas consumption increases by 1.7 percent per year. Increasing supplies of tight gas, shale gas, and coalbed methane support growth in projected worldwide natural gas use. Coal use grows faster than petroleum and other liquid fuel use until after 2030, mostly because of increases in China's consumption of coal and tepid growth in liquids demand attributed to slow growth in the OECD regions and high sustained oil prices.
The industrial sector continues to account for the largest share of delivered energy consumption; the world industrial sector still consumes over half of global delivered energy in 2040. Given current policies and regulations limiting fossil fuel use, worldwide energy-related carbon dioxide emissions rise from about 31 billion metric tons in 2010 to 36 billion metric tons in 2020 and then to 45 billion metric tons in 2040, a 46-percent increase.
P20 has a market
It doesnt matter, this turd is toast never to see 10 cents EVER again. Bob will stroke out after a while and this company will no longer exist. Give the floors one last sweep, shut off the lights before pad locking the doors
Day's Range 0.0611 - 0.0699 shake shake shake that monkey tree, Freeturd will be seeing .05 banana's next year, maybe Thursday after the PR that the SEC is investigating them?
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm341876.htm
November 29, 2012
Robert D. Battis
Founder, President & CEO
Laser Energetics, Inc.
3535 Quaker Bridge Road
Suite 700
Mercerville, NJ 08619
http://www.laserenergetics.com
Dear Mr. Battis:
This letter is in follow-up to multiple communications from the Food and Drug Administration (FDA) to your firm regarding the Dazer Laser Defender™ model family and Dazer Laser Guardian™ model family. In summary, in April 2010 you communicated by telephone and email with FDA Health Promotion Officer CAPT Dan Hewett, regarding your firm’s intention to respond to an April 6, 2010 letter from FDA that raised questions and concerns regarding your laser product’s compliance with federal regulations. Your firm was requested to provide a reply within 30 working days from the date of the letter.
FDA received an email from you dated April 23, 2010 which requested a meeting with FDA on May 7, 2010 to discuss the questions and concerns in the FDA the letter. Your email suggested that prior to the meeting, FDA should execute an attached Non-disclosure Agreement (NDA). On May 4, 2010 FDA stated by email that the NDA was not necessary because it is FDA policy to treat all discussions with firms it regulates as confidential. FDA requested an agenda prior to the meeting. No agenda was provided, and the meeting did not take place. Your firm did not provide a formal response to the April 6, 2010 letter, and FDA received no reply within the requested 45 days to a follow-up letter sent June 8, 2012.
According to FDA records, Laser Energetics, Inc. (hereafter, “the firm”) is not in compliance with the following FDA regulations:
1. 21 CFR 1002.10 Product Reports. The manufacturer of a product requiring a product report shall submit a product report to CDRH. Specifically, the firm failed to provide a product report to FDA for its Dazer Laser™ and BrightStar™ Alexandrite laser products. Product reports are necessary prior to the introduction of laser products into commerce.
2. 21 CFR 1002.13 Annual Reports. The manufacturer of a product requiring an annual report shall submit an annual report summarizing the contents of records required to maintained by § 1002.30(a). Specifically, FDA has not received any annual reports from the firm.
3. 21 CFR 1003.11 Determination by Secretary that product fails to comply or has a defect. The firm failed to respond to letters dated April 6, 2010 and June 8, 2012 that required a written response to FDA with the number of referenced products that have been produced and number that have left the place of manufacture. Be advised that failure to provide the information called for in the letters is considered a violation of Section 537(b) and 538(a)(2) of the Federal Food, Drug, and Cosmetic Act (the Act), Chapter V, Subchapter C Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968).
4. 21 CFR 1040.11(b) Surveying, leveling and alignment (SLA) laser products. The Dazer Laser products appear to be Class IIIb products which fail to comply with the class limits in § 1040.11(b) applicable to surveying, leveling and alignment laser products. Specifically, all Dazer Laser model families are limited to Class I, IIa, II or IIIa in the visible and Class I in the infrared or equivalent IEC Classes 1, 2, or 3R.
5. 21 CFR 1010.4 Variances. The firm failed to apply for a variance from the performance standard for surveying, leveling and alignment laser products that exceed Class IIIa or International Electrotechnical Commission (IEC) Class 3R. A variance approval is necessary prior to the introduction of Class IIIb or IV, and IEC Class 3B or 4 SLA laser products into commerce.
Once the use of a product is determined to be a SLA product within the meaning of 21 CFR 1040.10(39), the product is subject to laser class limitations in 21 CFR 1040.11(b). The requirements for SLA products are "designed to transmit laser radiation through open space for measuring and positioning purposes" (38 Federal Register, FR 34084, at 34085; December 10, 1973). The requirements are intended to "impose appropriate upper limits on the accessible laser emission from such products consistent with their intended function and the generally unrestricted environments in which they are used".
The uses of the Dazer Laser™ products are consistent with the uses of products that FDA has considered to be SLA products. Such laser products include products described as target pointer illuminator aiming, tactical laser illuminator, infrared zoom illuminator, and laser illuminator. Illuminator, alignment, target designation, pointing, or any similar description of a laser product for use in alignment or positioning provides a basis for classification of a laser product as a surveying, leveling, or alignment laser product. The divergence of the beam is not a factor in this classification because straight line alignment is not dependent upon the width of the beam or the distance between the source and termination of the beam.
For the reasons stated above, one or more of your laser products may not be compliant with the Class I infrared and/or Class IIIa visible class limits in 1040.11(b). CDRH intends that where the CFR specifies that laser products must conform to 1040.11(b), International Electrotechnical Commission (IEC) laser classes 1, 2, and 3R do not exceed these class limits for visible and invisible laser emissions. Please note the IEC laser classes 1M, 2M, 3B and 4 do not conform to 1040.11(b).
Your firm should work through the performance standard under 1040.10 and .11 to find the previously stated class limit and product reporting regulations, note any non-compliances, correct them, and submit product reports under 21 CFR 1002.10.
After you re-assess your product(s) your firm is obligated under 21 CFR 1003.10 to notify FDA of all defects or non-compliances in the manner described in 1003.20. Since non-compliances potentially affect units that have entered into commerce, your firm may have obligations under Part 1004 to repurchase, repair or replace your laser products that have been sold to purchasers, dealers or distributors.
If any products exceed SLA product Class limits, a variance application approval is necessary before unsold products may enter into commerce.
Your internet website states that your products have military applications. It is the CDRH’s position that CDRH will not grant variances for products that allow the products to also be sold to the Department of Defense (DoD), based on a November 8, 2002 memorandum from the DoD Laser System Safety Working Group (LSSWG). Firms that sell laser products that do not comply with the performance standard, and are sold to the DoD, must seek prior authorization from a DoD contracting officer under FDA exemption no. 76EL-01DOD, which was granted in 1976 to allow DoD to procure laser products for reasons of combat, combat training or for classified reasons of national security. We request that you provide such a response no later than 15 days after receipt of this letter with the number of laser products which have been produced, the number of such products that have left the place of manufacture, and the current location of such products.
Be advised that failure to respond to this letter may be considered to be a violation of section 538(a)(4) of the Act, 21 U.S.C. § 360oo(a)(4). FDA is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in section 539 of the Act, 21 U.S.C. § 360pp.
Persons who violate section 538 of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA.
When you have completed any necessary production changes to assure compliance of future units, CDRH determines that you have established an adequate quality testing program, and you have submitted the required reports and report supplements, you may resume introduction of these products into commerce. Note, you must correct the non-compliances with an approved CAP for all sold products.
Copies of the Federal Performance Standards, compliance guides, radiation safety product report guides, and other documents related to laser products are available on FDA’s web site at: http://www.fda.gov/Radiation-EmittingProducts/default.htm.
Your response should be sent to:
Chief, Magnetic Resonance and Electronic Products Branch
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
10903 New Hampshire Ave., WO66-4621
Silver Spring, Maryland 20993-0002
If you have any questions regarding the content of this letter, you may contact CAPT Dan Hewett, Health Promotion Officer at (301) 796-5864 or by internet electronic mail at Daniel.Hewett@fda.hhs.gov.
Sincerely yours,
/S/
Alberto Gutierrez, Ph.D.
Director
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health
Your internet website states that your products have military applications. It is the CDRH’s position that CDRH will not grant variances for products that allow the products to also be sold to the Department of Defense (DoD), based on a November 8, 2002 memorandum from the DoD Laser System Safety Working Group (LSSWG). Firms that sell laser products that do not comply with the performance standard, and are sold to the DoD, must seek prior authorization from a DoD contracting officer under FDA exemption no. 76EL-01DOD, which was granted in 1976 to allow DoD to procure laser products for reasons of combat, combat training or for classified reasons of national security. We request that you provide such a response no later than 15 days after receipt of this letter with the number of laser products which have been produced, the number of such products that have left the place of manufacture, and the current location of such products.
CANT sell LIE's flashlights ANYWHERE to ANYBODY in the US
Did you forget about the FDA sanctions barring LEI from hussling its wares conus or is that smoke and mirrors too?
during the discovery phase, they'd uncover who did the big rah rah's promoting LNGT to the masses. Dan Schall had helper elves donjcha know and those trading accounts held by the elves would be of interest to a few judges in district 1
Its been like that for a least a year that I know of
http://whois.net/whois/msgi.com
We need developmental news. This puppy is sitting on the deck. 1 sensor sale for anything and this one goes vertical
MSGI Technology Solutions, Inc., formerly MSGI Security Solutions, Inc., is developing solutions for commercial and governmental organizations. The Company is developing a business that leverages information and technology. The Company's clients include private and public-sector organizations focused on homeland security, law enforcement, and military and intelligence operations that support anti-terrorism and national security interests, medical service providers, and energy service producers and providers. In August 2009, the Company incorporated wholly owned subsidiary Nanobeak, Inc., a nanotechnology company focused on carbon based chemical sensing for gas and organic vapor detection. In September 2009, the Company incorporated wholly owned subsidiary Andromeda Energy Inc., a company focused on scalable alternative energy solutions employing National Aeronautics and Space Administration (NASA) developed nanotechnology.
http://www.msgisecurity.com
I just bot 5400 @ .055 to round off a position in one of my accounts. Only spent $305.49. This time next year will I regret it? Probably NOT
Sensible investment??? LOL that must be why the FDA informed Bob that his magic flashlights CANT BE SOLD in the United States. If uncle Sam doesnt want them what makes you think the Queen bee would be any different,
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=95225995
investment...........ROFLMAO!!!
APMEX check there
I have had a open order for 1,000,000 at .001 for weeks and this POS just wont fill
Who would your prefer to lead the competency bandwagon? The CTO is busy building machines making those inanimate objects work as he designed. There is no play book here other than the technical orders he writes. We have a new CEO who has 6 million of his own monies invested and lets not forget all of the boots on the ground reports of machine progress and tanker movements. So who exactly should we vote in to lead the pack?
The clowns from RKT tried to ruin JBI for a greedy pig whale because P20 doesnt work? They treated this system like a toy, throwing in all kinds of crap to see for themselves. They broke it, oops! John !!!! get John he'll fix it....
Those clowns are history what remains is the innovator and a team of skilled professionals doing their best to turn this company around.
You call selling 250,000 gallons of water a month progress? The only progress Aqueous has brought to the table is they're a legit company. Out of all the companies Freeturd has JV'd or LOI'D with, these guys have their paperwork in order. Get a Pacer account and look into management then read up on all the old PR's with fake companies
I havent followed them in a long while, Dr Buckwilde or what ever his name is in Loma checks out as do his affiliates. JB joined forces with them to make a gadget that will enhance mankind. No one said anything about buying anything but keep them on the radar. When 1 nanobeak sensor hits the market, the rest of them will hit too
The "other" stock has machines and a usable end product which has all beven developed in less than 5 years. Major difference between what they PR and what this scam has PR'd to date. NOTHING Freeturd has PR'd has ever come true, never mind fruition. Freeturds share price keeps swirling downward, Im sure the person who dropped 57K the other day is kicking themselves that they didnt wait a little longer, that clown is already down 30% soon to be 50% then 100% as this Scam implodes.
Look up VIRA and the JV between them and MSGI, You already know about VNTH, look in the IBOX, lol its ALLLLLLLLLLLLLLL there
Sometimes its hard to be a JBI investor. Giving all your money to just one man. You have bad times. And he'll have good times. Doin' things that you dont understand. But if you love him, you'll forgive him even though he's hard to understand. And if you love him, oh be proud of him. 'Cause after all he's just a man.
Tammy Whinette
Isnt it painful to watch all those dollars vanish in mid air? Thank Bob for that progress. Thank the unnamed mid-western hospitals that didnt want to be affiliated with LNGT for their super dooper dollar store flashlights. Or the police departments who couldnt figure out how to turn the Luke Skywalker model 17 on then shelved it to collect dust in the bowls of the department.
Will .05 rear its ugly head before 2013 is finished??? Single digit asks are looking like the norm these days. Holding on to FSNR is getting a little hairy. How long before the apes starting howling in the tree's?
In @ 3.74 out @ 3.94, that little .20 gain surpasses the .05 cent divy. I just LOVE dividend payers :)
Single digit asks are all lined up for 2014. SINGLE DIGIT! Freeturd has more laughs than a barrel of monkeys. Unfortunately the shareholders who bought in on the hype at higher levels arent laughing much. On a positive note, 100 shares can be had for less than a bushel of banana's
That must be why he works 20 hours a day building machines and helping to correct all of the F ups created by the bozo's from RKT
Ihub has a tutorial on investing, learn from those clowns Jack A
Oh Baby she's flying now, .08 ask, pretty soon you'll be able to buy this one with banana's
ROFLMAO at Freeturd
Some people get in and HOLD for the dividend which is stupid IMO, I like to jump in just for the dividend. Dont marry these companies, just trade in and out for the dividend. Get it?
Too bad ARR cant follow suit like WMC is. Those guys are paying a special 4thQ dividend of 2.35 a share. Maybe someday ARR will rake in those kinds of numbers. :)
PASADENA, Calif., Dec. 19, 2013 /PRNewswire/ -- Western Asset Mortgage Capital Corporation (WMC) announced today that its Board of Directors has declared a fourth quarter/year-end dividend of $2.35 for each common share payable in a combination of cash and stock.
http://en.wikipedia.org/wiki/NASA_Ames_Research_Center
at Ames, anything is possible,
Watching the development of VNTH is promising. Signing on major military names to their BOD tells me good things are in the works. People dont generally lend their name and credibility to something unless they feel its genuinely reputable. Jeremy has the support of NASA and soon to be military contracts for his chemical sensor. That combined with the medical sensors being introduced.........well, we're on the ground floor waiting for the elevator doors to open.
Happy New Year!!!... 2014 should prove to be..... spectacular
What ever happened to the Carrol Unit O&G well that was hyped as being a FSNR ASSet Go back through all of their PR's. Hydrex is a good example of smoke and mirrors. MEA corp another bonafide ghost that never came to be. Every PR released has been total bullshit
oh NO the ask is .075 and di di diving
that always spells confidence to me! ROFLMAO
3:13-cv-02811-PGS-TJB LIGHT POD, INC. et al v. LASER ENERGETICS, INC. et al
Peter G. Sheridan, presiding
Tonianne J. Bongiovanni, referral
Date filed: 05/01/2013
Date of last filing: 12/12/2013
Office: Trenton Filed: 05/01/2013
Jury Demand: Both Demand:
Nature of Suit: 190 Cause: 28:1332 Diversity-Breach of Contract
Plaintiff: LIGHT POD, INC. represented by JUSTIN MICHAEL COHEN
Phone: 215-985-1300
Email: jcohen@rbalawfirm.com
Plaintiff: LOTHAR BUDIKE, JR. represented by JUSTIN MICHAEL COHEN
Phone: 215-985-1300
Email: jcohen@rbalawfirm.com
Defendant: LASER ENERGETICS, INC. represented by BRYAN MICHAEL BUFFALINO
Phone: 609-791-7011
Email: bbuffalino@stark-stark.com
Defendant: LASER ENERGETICS, INC. represented by SCOTT I. UNGER
Phone: (609) 896-9060
Email: sunger@stark-stark.com
Defendant: ROBERT BATTIS represented by BRYAN MICHAEL BUFFALINO
Phone: 609-791-7011
Email: bbuffalino@stark-stark.com
Defendant: ROBERT BATTIS represented by SCOTT I. UNGER
Phone: (609) 896-9060
Email: sunger@stark-stark.com
Counter Claimant: ROBERT BATTIS represented by BRYAN MICHAEL BUFFALINO
Phone: 609-791-7011
Email: bbuffalino@stark-stark.com
Counter Claimant: ROBERT BATTIS represented by SCOTT I. UNGER
Phone: (609) 896-9060
Email: sunger@stark-stark.com
Counter Claimant: LASER ENERGETICS, INC. represented by BRYAN MICHAEL BUFFALINO
Phone: 609-791-7011
Email: bbuffalino@stark-stark.com
Counter Claimant: LASER ENERGETICS, INC. represented by SCOTT I. UNGER
Phone: (609) 896-9060
Email: sunger@stark-stark.com
Counter Defendant: LIGHT POD, INC. represented by JUSTIN MICHAEL COHEN
Phone: 215-985-1300
Email: jcohen@rbalawfirm.com
Counter Defendant: LOTHAR BUDIKE, JR. represented by JUSTIN MICHAEL COHEN
Phone: 215-985-1300
Email: jcohen@rbalawfirm.com
WARNING LETTER
November 29, 2012
Robert D. Battis
Founder, President & CEO
Laser Energetics, Inc.
3535 Quaker Bridge Road
Suite 700
Mercerville, NJ 08619
http://www.laserenergetics.com
Dear Mr. Battis:
This letter is in follow-up to multiple communications from the Food and Drug Administration (FDA) to your firm regarding the Dazer Laser Defender™ model family and Dazer Laser Guardian™ model family. In summary, in April 2010 you communicated by telephone and email with FDA Health Promotion Officer CAPT Dan Hewett, regarding your firm’s intention to respond to an April 6, 2010 letter from FDA that raised questions and concerns regarding your laser product’s compliance with federal regulations. Your firm was requested to provide a reply within 30 working days from the date of the letter.
FDA received an email from you dated April 23, 2010 which requested a meeting with FDA on May 7, 2010 to discuss the questions and concerns in the FDA the letter. Your email suggested that prior to the meeting, FDA should execute an attached Non-disclosure Agreement (NDA). On May 4, 2010 FDA stated by email that the NDA was not necessary because it is FDA policy to treat all discussions with firms it regulates as confidential. FDA requested an agenda prior to the meeting. No agenda was provided, and the meeting did not take place. Your firm did not provide a formal response to the April 6, 2010 letter, and FDA received no reply within the requested 45 days to a follow-up letter sent June 8, 2012.
According to FDA records, Laser Energetics, Inc. (hereafter, “the firm”) is not in compliance with the following FDA regulations:
1. 21 CFR 1002.10 Product Reports. The manufacturer of a product requiring a product report shall submit a product report to CDRH. Specifically, the firm failed to provide a product report to FDA for its Dazer Laser™ and BrightStar™ Alexandrite laser products. Product reports are necessary prior to the introduction of laser products into commerce.
2. 21 CFR 1002.13 Annual Reports. The manufacturer of a product requiring an annual report shall submit an annual report summarizing the contents of records required to maintained by § 1002.30(a). Specifically, FDA has not received any annual reports from the firm.
3. 21 CFR 1003.11 Determination by Secretary that product fails to comply or has a defect. The firm failed to respond to letters dated April 6, 2010 and June 8, 2012 that required a written response to FDA with the number of referenced products that have been produced and number that have left the place of manufacture. Be advised that failure to provide the information called for in the letters is considered a violation of Section 537(b) and 538(a)(2) of the Federal Food, Drug, and Cosmetic Act (the Act), Chapter V, Subchapter C Electronic Product Radiation Control (formerly the Radiation Control for Health and Safety Act of 1968).
4. 21 CFR 1040.11(b) Surveying, leveling and alignment (SLA) laser products. The Dazer Laser products appear to be Class IIIb products which fail to comply with the class limits in § 1040.11(b) applicable to surveying, leveling and alignment laser products. Specifically, all Dazer Laser model families are limited to Class I, IIa, II or IIIa in the visible and Class I in the infrared or equivalent IEC Classes 1, 2, or 3R.
5. 21 CFR 1010.4 Variances. The firm failed to apply for a variance from the performance standard for surveying, leveling and alignment laser products that exceed Class IIIa or International Electrotechnical Commission (IEC) Class 3R. A variance approval is necessary prior to the introduction of Class IIIb or IV, and IEC Class 3B or 4 SLA laser products into commerce.
Once the use of a product is determined to be a SLA product within the meaning of 21 CFR 1040.10(39), the product is subject to laser class limitations in 21 CFR 1040.11(b). The requirements for SLA products are "designed to transmit laser radiation through open space for measuring and positioning purposes" (38 Federal Register, FR 34084, at 34085; December 10, 1973). The requirements are intended to "impose appropriate upper limits on the accessible laser emission from such products consistent with their intended function and the generally unrestricted environments in which they are used".
The uses of the Dazer Laser™ products are consistent with the uses of products that FDA has considered to be SLA products. Such laser products include products described as target pointer illuminator aiming, tactical laser illuminator, infrared zoom illuminator, and laser illuminator. Illuminator, alignment, target designation, pointing, or any similar description of a laser product for use in alignment or positioning provides a basis for classification of a laser product as a surveying, leveling, or alignment laser product. The divergence of the beam is not a factor in this classification because straight line alignment is not dependent upon the width of the beam or the distance between the source and termination of the beam.
For the reasons stated above, one or more of your laser products may not be compliant with the Class I infrared and/or Class IIIa visible class limits in 1040.11(b). CDRH intends that where the CFR specifies that laser products must conform to 1040.11(b), International Electrotechnical Commission (IEC) laser classes 1, 2, and 3R do not exceed these class limits for visible and invisible laser emissions. Please note the IEC laser classes 1M, 2M, 3B and 4 do not conform to 1040.11(b).
Your firm should work through the performance standard under 1040.10 and .11 to find the previously stated class limit and product reporting regulations, note any non-compliances, correct them, and submit product reports under 21 CFR 1002.10.
After you re-assess your product(s) your firm is obligated under 21 CFR 1003.10 to notify FDA of all defects or non-compliances in the manner described in 1003.20. Since non-compliances potentially affect units that have entered into commerce, your firm may have obligations under Part 1004 to repurchase, repair or replace your laser products that have been sold to purchasers, dealers or distributors.
If any products exceed SLA product Class limits, a variance application approval is necessary before unsold products may enter into commerce.
Your internet website states that your products have military applications. It is the CDRH’s position that CDRH will not grant variances for products that allow the products to also be sold to the Department of Defense (DoD), based on a November 8, 2002 memorandum from the DoD Laser System Safety Working Group (LSSWG). Firms that sell laser products that do not comply with the performance standard, and are sold to the DoD, must seek prior authorization from a DoD contracting officer under FDA exemption no. 76EL-01DOD, which was granted in 1976 to allow DoD to procure laser products for reasons of combat, combat training or for classified reasons of national security. We request that you provide such a response no later than 15 days after receipt of this letter with the number of laser products which have been produced, the number of such products that have left the place of manufacture, and the current location of such products.
Be advised that failure to respond to this letter may be considered to be a violation of section 538(a)(4) of the Act, 21 U.S.C. § 360oo(a)(4). FDA is prepared to invoke regulatory actions if you fail to comply with these requirements. These actions may include an injunction and/or imposition of civil penalties as provided for in section 539 of the Act, 21 U.S.C. § 360pp.
Persons who violate section 538 of the Act are subject to civil penalties of up to $1,100 per violation and up to a maximum penalty of $355,000 without further notification by the FDA.
When you have completed any necessary production changes to assure compliance of future units, CDRH determines that you have established an adequate quality testing program, and you have submitted the required reports and report supplements, you may resume introduction of these products into commerce. Note, you must correct the non-compliances with an approved CAP for all sold products.
Copies of the Federal Performance Standards, compliance guides, radiation safety product report guides, and other documents related to laser products are available on FDA’s web site at: http://www.fda.gov/Radiation-EmittingProducts/default.htm.
Your response should be sent to:
Chief, Magnetic Resonance and Electronic Products Branch
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
10903 New Hampshire Ave., WO66-4621
Silver Spring, Maryland 20993-0002
If you have any questions regarding the content of this letter, you may contact CAPT Dan Hewett, Health Promotion Officer at (301) 796-5864 or by internet electronic mail at Daniel.Hewett@fda.hhs.gov.
Sincerely yours,
/S/
Alberto Gutierrez, Ph.D.
Director
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health
wow Beryl Wolk I forgot all about that clown!!! Its like the blind leading the blind here, everyone is mad at those clearly pointing out this scam while they defend the crooks who stole their money by issuing phoney headlines of sales to unnamed organizations to sell shares. The share price is the ultimate indicator that LNGT is a scam and the icing on the cake is the FDA letter restricting Battis from peddling his wares here in the United States. LNGT was a good flipper a few years ago but that momentum has dried up leaving a slew of bagholders. This stock will never be a dollar if Bob is forbidden from selling his merchandise. LMAO at a dollar. LNGT will be lucky to see a penny again, ROFLMAO at a dollar!!! Dont listen to us, listen to all of the RED in your portfolio
I know that you are, like many others. Everything was gung ho MSGI until Jeremy bought Vantage and that knocked the wind out of a lot of sails. The filings still have to be updated, maybe that will happen once VNTH books some sales and MSGI starts pocketing the licensing rights. MSGI is the parent company with many wholly owned subsidiaries with the newest and most profitable (future projection) being Vantage health.
until we get anything from Jeremy everyone is sitting on piles of dead money