That sounds extremely fishy NasRAT should of had that warning letter fixed by now. So he was withholding that for a whole. All his lies and secrets are catching up to him real quick.
I agree Something does not sound right And why have we not been told this before Imho this is a material event and should have been disclosed since it holding up more than one anda... I assume the the lawyers will be making a class action pretty soon... I for one will be looking for an exit asap
The warning letter’s effectiveness depends on conscientious follow-up
"The FDA completes appropriate follow-up in approximately 97 percent of cases. Followup may involve reinspecting the firm, soliciting documentation of corrections, or meeting with the firm to address compliance issues. In other cases, FDA does not need to follow up except to ensure that the firm responds to the warning letter. Follow-up inspections frequently uncover other violations, but FDA rarely has to initiate compliance actions. On average, follow-up inspections take place more than 9 months after the warning letter is issued." (https://oig.hhs.gov/oei/reports/oei-09-97-00381.pdf)
May have struck more gold here.. This is likely more telling than anything. Another pharma received the same type of warning letter Elite did regarding postmarketing adverse drug experiences (PADE) and had a subsequent resolution. This was the only one I could find as far back as 2012:
***Basically from what I can tell, this means Heritage Pharmaceuticals was issued a warning letter on 11/05/2015 for PADE as well. The "closeout date" for this warning letter was 12/28/16.***
4-1-8 - Warning Letter Follow-Up
"The issuing district or center will evaluate the response to the Warning Letter. If the response is inadequate, or if no response is received, the district or center will begin follow-up action as necessary to achieve correction. If the Warning Letter contains violations that by their nature are not correctable, then no close-out letter will issue.
If the response appears adequate, the district or center will verify that commitments have been fulfilled and that correction has been achieved, and will notify other appropriate agency units. Usually, the standard for verifying that corrections have been implemented will be a follow-up inspection. Follow-up inspections should be conducted promptly after the agreed upon date of completion of the promised corrections.
Acknowledgment Of Response To A Warning Letter
The district or center that issued the Warning Letter should acknowledge, in writing, receipt of Warning Letter responses. The district or center should save a PDF copy of the issued correspondence under the Final Outcome tab in CMS, identified as doc type = "courtesy acknowledgment correspondence". Warning Letter responses regarding CTP Retailer Compliance Check Inspections are acknowledged with "Reply to Warning Letter Response" letters. CTP should save a PDF copy of the issued Reply letter under the "POST Action Mgt" tab in CMS, identified as doc type = "Letter of FDA's review of firm's response."
Warning Letter Close-out Letter
A Warning Letter close-out letter ("close-out letter") will not be issued based on representations that some action will or has been taken. The corrective actions must actually have been made and verified by FDA. The district or center that issued the Warning Letter should issue a close-out letter for Warning Letters issued on or after September 1, 2009, if the violations in the Warning Letter have been adequately addressed, and the following conditions have been met:
The firm replied to the Warning Letter with sufficient information to demonstrate that any listed violations have been adequately corrected; or
A follow-up inspection shows that implementation of the corrective actions was adequate, or, based on other verified, appropriate and reliable information, FDA determines that the follow-up inspection is not needed; and
The follow-up inspection (or other appropriate and reliable information) does not reveal other significant violations.
The issuing office will evaluate the firm’s response to the Warning Letter.
Where the district is the issuing office, the following procedure should be followed prior to issuance of a close-out letter. If the district performs an inspection to verify correction, the district may, but need not, ask the center whether it has a comment or objection prior to issuing a close-out letter. If the district decides not to inspect to verify correction, and the Warning Letter required center concurrence, the district will ask the center, via CMS, whether it has a comment or objection prior to issuing a close-out letter. The center will enter any comments or objections to the issuance of a close-out letter (i.e., FDA’s conclusion that the firm’s corrective actions are adequate to address the violations contained in the Warning Letter), via the center documents tab in CMS within 30 working days. If the center requests more time, an additional 30 working days should be granted. At the end of the 30 (or 60) working day period, the district will review the center’s comments or objections, if any, providing deference to the center in areas of the center’s expertise, and, where the center has provided comments or objections, will issue the close-out letter only if consensus is reached with the center.
Districts or centers should issue close-out letters within a total of 65 working days of having the necessary information upon which to make a decision. Use the model "close-out letter" in Exhibit 4-2. The issuing district or center is responsible for ensuring that a PDF copy of the final, signed close-out letter is added into CMS.
A close-out letter does not relieve the recipient from their responsibility for taking all necessary steps to assure sustained compliance with the Act, and all other applicable requirements. If a subsequent inspection reveals problems with the adequacy or sustainability of the corrections that were taken in response to the Warning Letter, such violations would be considered serious. If FDA observes violations during subsequent inspections or through other means, we may take enforcement action without further notice.
Hope this helps, my friends. Amazing what you can find with a little research. (Apologize if any of this was posted previously and I missed it!)
Looks like we could see a warning letter resolution anytime now but may have at most a couple more months left. Nasrat did say they believe the last FDA inspection was "favorable", that they responded to the FDA on the warning letter/corrections and they that they hope and expect all issues were addressed to the FDA's satisfaction. He states there were no further write ups on anything at this last inspection. This must have been a re-inspection that occurred recently. He also mentions that they were inspected for cGMP and 2 pre-approval inspections. (for new ANDAs??)
Listen at around the 18 min 20sec mark as well as 38-39 min mark on the audio CC replay right near the end, while keeping the research from this post in mind.
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