FDA 483 - Union Carbide Corporation - October 24, 2024

The Food and Drug Administration (FDA) issued a Form 483 to Union Carbide Corporation following an inspection of their Active Pharmaceutical Ingredient (API) manufacturing facility in Hahnville, LA, conducted from October 21-24, 2024. The inspection identified three key observations indicating non-compliance with Good Manufacturing Practices.

Firstly, the company's production records were found to be incomplete, specifically lacking documented actual results for critical process parameters, such as temperature and time, in batch records for Polyethylene Glycol (PEG) 3350. For instance, lot D684NSGFB1 was released without these parameters being reviewed.

Secondly, deviations from established procedures were not adequately investigated. A customer complaint regarding a stability failure (out-of-specification formaldehyde) for PEG 3350 batch D684L35FB2 highlighted an uninvestigated increase in temperature during production, which was not recorded in the batch record, despite its potential quality impact.

Lastly, equipment used in the manufacturing of PEG 3350 was not properly qualified before being used for commercial batches. This deficiency was linked to the stability failure observed in batch D684L35FB2. Union Carbide Corporation is expected to respond to these observations with comprehensive corrective and preventive actions to ensure adherence to federal pharmaceutical manufacturing regulations.