FDA EIR - Union Carbide Corporation - January 19, 2017

An FDA surveillance inspection of Union Carbide Corporation in Hahnville, LA, was conducted from January 17-19, 2017. The inspection, which focused on active pharmaceutical ingredient (API) manufacturing for polyethylene glycol (PEG) and piperazine, adhered to the Active Pharmaceutical Ingredient Inspection Program and Animal Drug Manufacturing Inspections guidelines. While no FDA Form 483 was issued, several observations required management attention.

Key issues identified included stability failures for both PEG and piperazine. For PEG, a stability failure was discovered late, and the company initially failed to notify customers or the FDA, relying instead on a risk assessment. For piperazine, an investigation into a stability failure was incomplete and suggested issues with storage containers. Discussions also covered data integrity; new electronic logbooks were not consistently linked or referenced in batch records, and initial paper notes were not consistently maintained as raw data. The inspector emphasized the need to maintain all raw data and ensure consistent record-keeping. Lastly, a discrepancy in the Site Leader’s training record was noted, with a recommendation for appropriate training relevant to their oversight responsibilities. Management committed to addressing these issues, including improving stability testing timeliness, ensuring proper notification for confirmed failures, and refining raw data management procedures.