Medizone Intl. (fka MZEIQ)

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here you go....

Tuesday, May 25, 2010

ANOTHER FDA WARNING LETTER FOR JOHNSON & JOHNSON

http://americanfraud.com/contact.aspx

http://americanfraud.blogspot.com/2010/05/another-fda-warning-letter-for-johnson.html

The latest warning letter to Johnson & Johnson CEO Bill Weldon reveals that J&J executives have once again refused to properly investigate consumer complaints or to resolve shoddy and illegal manufacturing practices.

The FDA inspected J&J subsidiary Advanced Sterilization Products (ASP), located in Irvine, California on June 1, 2009, through September 28, 2009. The FDA found problems in the manufacturing of these products: STERRAD models, 50, 100S, 200, NX and 100NX Hydrogen Peroxide Gas Plasma Sterilizers, STERRAD CycleSure Biological Indicator (BI), CIDEX disinfectants (including the CIDEX Activated Dialdehyde Solution), CIDEX Test Strips, and the Evotech Cleaner and Reprocessor.

J&J is manufacturing adulterated products:


"This inspection revealed that the devices are adulterated within the meaning of section 501(h) of the Act, (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for manufacturing, packaging, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements for the Quality System (QS) regulation."


The FDA found that J&J failed to establish and maintain adequate procedures for verifying or validating the corrective and preventive actions to resolve problems uncovered by the FDA.

"...actions taken by your firm to correct and prevent recurrence of these events were inadequate"

After problems were identified by the FDA, the problems continued. J&J received more customer complaints, which they also failed to investigate or resolve.


"Your film initiated CAPA 08-000008 on February 5, 2008, to address 26 customer complaints alleging hydrogen peroxide contact when handling STERRAD CycleSure Biological Indicators (BI's), where media ampoules were found broken following Sterrad sterilization cycles. Your film identified the root cause as small cracks in the media ampoules causing the ampoules to break during the sterilization cycle and causing hydrogen peroxide to condense on the BI. Your firm's CAPA actions were to revise the CycleSure Instructions for Use by adding the wearing of gloves when handling BI's and ensuring updates of the media ampoule inspection and the handling procedure during the assembly of the BI's. However, your firm did not conduct an effectiveness check to assess whether the actions were effective."

Johnson & Johnson's response was not adequate:


"Your firm's response dated October 16, 2009, is not adequate because your firm did not provide a commitment to conduct effectiveness checks on approximately sixty-six (66) STERRAD 100S units after the required field corrective action had been taken. In addition, your firm stated that the (b)(4) was set as a collective effectiveness criterion for all STERRAD models but did not provide effectiveness criterion and (b)(4) for each STERRAD model. Additionally, your response is inadequate because no assessment was conducted to determine if the actions were effective when the Corrective Actions were implemented. A total of five (5) complaints were received but your firm failed to provide a summary of the complaints and the time period the assessment was conducted."

Johnson & Johnson used outdated materials


"However, your firm's CAPA action was ineffective in that your film failed to verify that all published materials by the MDM were current prior to inclusion of these devices in the SSG as stated in SP 101258 Revision C, Step 4.1. For instance:


a. Your film used a three (y)ear old Customer letter, dated December 7, 2005, to support inclusion of the (b)(4) on the SSG, August 6, 2008.


b. Your firm used information indicating that the Sterrad 100S could provide adequate sterility assurance for the (b)(4) as justification to add the device to the SSG on August 6, 2008. However this information is over two years old (dated February 3, 2006).


c. Your firm used a two year old cover letter for a user manual (dated March 9, 2006) from the MDM stating that the device, (b)(4) is compatible with Sterrad Sterilization Systems and was added to the SSG on August 6, 2008.


d. The supporting documentation to support inclusion of (b)(4) on the SSG is approximately 1.5 years old and was not included in the audit file at ASP prior to the start of the inspection.


e. There was no documentation accompanying the STERRAD Sterility Audit Form used to add the following devices to the SSG: (b)(4). In addition, Documentation used to add (b)(4) to the SSG was Dated March 2, 2007.


Regarding problems with the "Instruction For Use" (IFU) for CycleSure Biological Indicators, the FDA stated:


"Your response to this observation dated October 16, 2009, is not adequate because your firm did not sufficiently address the corrective action or the systemic corrective action within the design process to prevent this type of problem from occurring in the future."

Another laundry list of shoddy manufacturing practices at another J&J operating company resulting in adulterated products leaving a J&J manufacturing plant.