FDA’s ‘Bizarre’ Warning Letter Findings Highlight Persistent GMP Failures

The European Compliance Academy (ECA) regularly reports on FDA Warning Letters, which often reveal unusual—and sometimes alarming—compliance lapses. A review of recent cases highlights several “bizarre” deficiencies across manufacturing sites.

Premises & Equipment: Rusty equipment, product residues, and uncontrolled transfers between cleanrooms remain recurring issues. In one case, smoke studies even showed turbulence caused by a transport trolley—yet the flawed practice continued.

Quality Control: Some firms relied solely on the Chinese Pharmacopoeia without proving equivalence to U.S. standards, while others neglected impurity monitoring in stability studies.

Validation Failures: FDA continues to cite missing process and cleaning validation—even though relevant guidance has been in place for decades.

Aseptic Practices & Documentation: Inspectors noted employees touching sterile equipment with bare skin, ignored contamination in media fills, fabricated data, backdated signatures, and even certificates sent via WhatsApp—later deleted.

Though sometimes absurd, these findings underscore serious risks. As the ECA notes, such companies hardly inspire consumer trust.

27-08-2025