Akom Pharmaceuticals, Inc. – FDA 483, Jun 10, 2016

On June 10, 2016, the FDA issued a Form 483 to Akorn Pharmaceuticals, Inc., a sterile drug product manufacturer in Decatur, IL, following an inspection from June 1-10, 2016. The inspection revealed six observations related to production, quality, laboratory controls, and facilities/equipment systems.

**Production System:** * **Observation 1:** Deviations from written production and process control procedures were not recorded and justified. A media fill failure (Batch 14-14-01453) on November 26, 2014, was attributed to slow production, operator fatigue, and equipment malfunctions (broken bolt on table, loading cart issues). Despite these issues, which would normally warrant abortion of a commercial batch, the media fill proceeded, violating SOP AA204. Production personnel also failed to reject exposed units and unloaded units, violating SOPs AA204 and AA143. No occurrence log was used for the filling room, and the equipment failure/intervention was not observed by Quality or Production Oversight, hindering investigation into contamination.

**Quality System:** * **Observation 2:** The quality control unit's responsibilities and procedures were not fully followed. There was no system to account for the total number of pages of forms used for batch control and test results (issued vs. used/discarded/copied), and form issuance