3. Your firm failed to investigate specific discrepancies related to the lots of impure drugs supplied to your customers. We learned that heparin sodium lots manufactured at your facility were determined to be contaminated with OSCS. At the time of the inspection, no investigation had been conducted into this repeated and unacceptable contamination.Only one inference is possible from these detailed complaints by the FDA: The Chinese don’t seem to care about the safety of a drug intended for IV use with the sickest of Americans. Such complete failure could not have slipped by even the most cursory of investigation.
From our investigation, it appears that your customer requested that your firm investigate the OSCS contamination. Although the contamination of these lots was discussed during the inspection, you apparently had not initiated an investigation to determine the root cause of the contamination, identified whether other lots were implicated, or taken appropriate corrective actions to prevent recurrence of this contamination.
Your firm’s failure to investigate these significant customer complaints is a serious deviation from CGMP. It is your firm’s responsibility to ensure that drugs manufactured at your facility are produced in compliance with CGMP. This includes establishing adequate systems to detect such quality issues before an adulterated product is distributed, and promptly implementing corrective measures to prevent recurrence.
No information was provided to assure that any of your firm’s internal practices or upstream sources (e.g., suppliers) that may have been involved in the contamination of the 19 lots produced has been identified and removed from your supply chain. Please include in your written response to this letter a copy of all investigations regarding OSCS that may have been conducted after the inspection, the root cause of the contamination, and the corrective actions implemented to prevent recurrence. Also include the list of the crude and other upstream suppliers for all of the contaminated lots.
The investigators were informed during the inspection that all lots of heparin sodium produced at your facility would be tested using the CE and NMR methods beginning in September 2008. Please state in your response whether your firm has begun to test the heparin sodium using these methods or if these analyses are being outsourced, and when this testing commenced. If your firm has decided to outsource these tests, include in your response the identity of the contract laboratory, their physical address and the qualification report.
Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.
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