FDA’s Aggressive Inspections Can Deep-Six Pending Filings

May 13, 2013

In recent months, FDA has been ramping up inspections of manufacturers who have pending filings for approval, notifications and other regulatory clearances. As a result, companies are finding their pending filings denied based on seemingly unrelated inspection observations.

For example, Gilead Sciences Inc. has disclosed that the FDA issued an inspection observation Form 483 response to a recent inspection of a Gilead plant. The 483 noted that inspectors observed manufacturing problems, including deficiencies in documentation and validation of certain quality testing procedures and methods.

Simultaneously, Gilead was applying for the FDA to endorse the expanded use of certain ingredients in an HIV drug. The FDA, however, issued a complete response letter not endorsing the broader use of the component ingredient. In the FDA’s response denying the endorsement, the FDA noted the observed manufacturing deficiencies found during the inspection

In light of the current environment of increased and aggressive inspections, a manufacturer must work toward ensuring that not only is its application to the FDA in compliance with FDA requirements but that its physical facilities and manufacturing locations are also fully compliant with FDA requirements. It appears that when reviewing pending filings for approval, notifications and other regulatory clearances, the FDA is taking the position of holistically reviewing the manufacturer instead of narrowly addressing the issue presented in the pending filing.

If you have questions or issues relating to inspection, 483 responses or any filings with the FDA, please contact one of the authors.