FDA WARNING_LETTER - Akorn Inc. - August 30, 2018

The FDA issued a Warning Letter to Akorn, Inc. following an inspection of their Somerset, New Jersey drug manufacturing facility from July 23 to August 30, 2018. The letter identifies significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate out-of-specification (OOS) laboratory results and manufacturing deviations. Examples cited include an OOS osmolality result for ketorolac tromethamine ophthalmic solution with observed product defects (low volume, leakage, residue), and metal shavings found on aseptic filling equipment for lidocaine hydrochloride 2% jelly. Laboratory investigations into "trial" injections and OOS impurity results for azelastine hydrochloride and ciprofloxacin ophthalmic solutions were also deemed inadequate, with many remaining open for extended periods. 2. **Inadequate Computer System Controls and Data Integrity (21 CFR 211.68(b), 21 CFR 211.194(a)):** Data could be deleted and altered from laboratory instruments, and standalone instruments were not backed up. A database, usage logs, and audit trails were deleted from a particle counter. Numerous sample injection sequences lacked required signatures for review, and chemists had full administrator access to instrument computers, allowing data