FDA 483 - Baxter Healthcare Corporation - March 26, 2025

Baxter Healthcare Corporation in Guayama, PR, received a Form 483 following an inspection from March 24-26, 2025, for its drug manufacturing facility. The inspection revealed significant issues with the firm's quality control unit, specifically regarding the securing and storage of quality and production records. Investigators found original records, batch records, and unapproved documents discarded in trash cans and shredding bags, indicating a failure to maintain data integrity and follow established procedures for documentation and record management.