FDA 483 - Baxter Healthcare Corporation - July 19, 2024

An FDA inspection of Baxter Healthcare Corporation, a sterile drug manufacturer in Jayuya, PR, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to adequately investigate Out of Specification results and laboratory errors, maintain contemporaneous documentation, and ensure proper equipment cleaning and maintenance. These issues collectively compromise product quality, data integrity, and the sterility assurance of drug products.