Just Say No! Not a Good Idea for a Testing Lab

In a short Warning Letter issued by the FDA on August 29, 2019, the Agency informed a China-based testing firm that, because it refused inspection, that FDA would withhold approvals of any ANDA or NDA in which it was cited as a testing laboratory.  The FDA takes refusal of inspection very seriously and the impact on NDA or ANDA sponsors (or, for that matter, BLA or PMA applicants) could seriously delay approval of their applications.

The Warning Letter indicates that the target firm conducts active pharmaceutical ingredient characterization and testing.  The Agency warns that:

“Until FDA is permitted to inspect your facility and confirms compliance with current good manufacturing practice (CGMP), this office may recommend withholding approval of any new applications or supplements listing your firm as a drug manufacturer.”

The full Warning Letter can be found here.  Firms engaging with testing labs or other providers of outsourced services for which FDA inspection may be required should always have an upfront agreement or understanding with any outside facility that they will permit access to the FDA inspectors or they may face an unexpected delay in approval.