The FDA is closing out 2010 with a warning letter bang. It cites Synbiotics in Ahmadabad, India on two GMP-violation counts and expresses a lack of confidence in the API maker's ability to manufacture products to spec.
The recently posted warning contains the now-familiar tone of impatience coupled with the promise of re-inspection described in our report, "Frightening Phrases: Warning letter language to watch." The citations concern process-documentation and quality-system failures.
Inspectors noted during an August visit that the company shipped a product lot to the U.S. while having no procedures for change control, for out-of-spec and process-deviation investigations, for handling lab incidents and consumer complaints, and for conducting annual product reviews. The investigators describe their visit as an "inspection attempt."
Synbiotics acknowledged its process and quality-system shortcomings in a response following the inspection, according to the warning letter. Although the response includes the missing SOPs, the agency reminds the company that such operations elements are supposed to be in place prior to manufacturing. "Your quality system will be thoroughly reviewed during the next FDA inspection."
Another citation concerns incomplete process validation for the product shipped to the U.S. Synbiotics contends in its response that the lot in question met USP requirements both at release and during retain re-testing, according to the warning letter. Because the product met USP specs, the company reasons, it is "completely safe and there are no quality issues."
But the FDA disagrees, citing the company's own post-inspection response. "You have already acknowledged that process validation ha[d] not yet been completed at the time of manufacture and that your quality system 'was inadequate' and that 'critical Quality Assurance functions were missing.'"
- see Warning Letter 320-11-06