FDA 483 - Union Carbide Corporation - October 24, 2024

An FDA inspection of Union Carbide Corporation, an API manufacturer located in Hahnville, LA, was conducted from October 21-24, 2024. The inspection revealed several significant observations indicating non-compliance with manufacturing control standards, as documented in an FDA Form 483. The primary issues observed included incomplete production records. Specifically, critical process parameters such as temperature and time were not consistently recorded in batch production records for Polyethylene Glycol (PEG) 3350 before batches were released for distribution, exemplified by lot D684N5GFB1. Furthermore, the company failed to adequately investigate deviations from established procedures. An instance involved a customer complaint in April 2023 regarding out-of-specification formaldehyde levels in PEG 3350 batch D684L35FB2. Although an operator noted an increased temperature during production in March 2021, this was not documented in the batch record, nor was a timely investigation initiated to assess its impact on product quality. A third major observation concerned the use of unqualified manufacturing equipment. The firm used specific equipment to produce commercial batches of PEG 3350 for the U.S. market without full qualification. This issue was highlighted by a customer complaint about a stability failure for PEG 3350 batch D684L35FB2, which was manufactured during the equipment's performance qualification phase. These observations, issued under the Federal Food, Drug, and Cosmetic Act, necessitate prompt corrective actions from Union Carbide Corporation to address the identified deficiencies and ensure compliance with regulatory expectations for API manufacturing.