FDA EIR - Union Carbide Corporation - October 24, 2024

An FDA surveillance inspection of Union Carbide Corporation was conducted from October 21-24, 2024, in Hahnville, LA. The inspection focused on the firm's manufacturing of PEG 3350, an active pharmaceutical ingredient for human drug products, under Compliance Program 7356.002F and ICH Q7 guidelines. The inspection encompassed the company's Quality, Production, Materials, and Laboratory systems. Key observations included an inadequate investigation into a production deviation from 2021 that subsequently led to a customer complaint in April 2023, concerning a stability failure with formaldehyde out-of-specification. Furthermore, a corrective action for an off-specification temperature during March 2021 production was deemed insufficient. The inspection also highlighted a lack of documentation in batch records detailing critical process parameter settings during production. These findings, identified as "Objectionable Conditions," necessitate that Union Carbide implement comprehensive corrective and preventive actions to ensure adherence to good manufacturing practices for active pharmaceutical ingredients.