FDA 483 - Baxter Healthcare Corporation - July 19, 2024

An FDA inspection conducted at Baxter Healthcare Corporation in Jayuya, PR, from July 8-19, 2024, resulted in a Form FDA 483 citing significant observations regarding Current Good Manufacturing Practice (CGMP) violations for sterile drug manufacturing. The findings highlighted systemic issues across laboratory, quality, and production systems. In the laboratory, the company failed to thoroughly investigate unexplained discrepancies and Out-of-Specification (OOS) results, exemplified by inadequate bacterial endotoxin testing for Heparin Sodium and frequent unaddressed lab errors. Documentation deficiencies were also noted, with a failure to contemporaneously record data for incubators, growth promotion, and USP standard logbooks, compromising data integrity. Furthermore, bacterial endotoxin testing lacked consistent Positive Product Controls for each sample run, a critical omission for ensuring test reliability. Regarding the quality system, Baxter Healthcare did not submit follow-up information or estimated final report dates for initial Field Alert Reports to the FDA, as required. Production system observations included deficient equipment cleaning and maintenance, evidenced by dusty surfaces, foreign matter in sterilizer vessels, a damaged HEPA filter, and undocumented tank wear. Procedures to prevent microbiological contamination were also not followed, specifically lacking environmental air control plates during bioburden testing and exceeding personnel limits in controlled manufacturing areas. These observations, issued under regulatory frameworks like 21 CFR Part 211, necessitate prompt and comprehensive corrective actions from Baxter Healthcare Corporation to ensure the quality, safety, and integrity of their sterile drug products.