FDA Warns New Jersey OTC Drugmaker for Quality Unit Failures
New Jersey drugmaker A.P. Deauville received a warning letter from the FDA for repeat quality and cleaning violations for its OTC topical drugs.
An agency inspection of the New Brunswick facility revealed serious quality lapses. Specifically, the firm didn’t identify or investigate manufacturing deviations for batches released to market. One product batch was not processed and mixed at the temperature and speed listed in the manufacturing instructions.
The company also lacked written procedures for quality unit responsibilities, change controls, and investigations for OOS, deviations and complaints.