FDA 483 - Baxter Pharmaceutical Solutions, LLC

Baxter Pharmaceutical Solutions LLC, a contract manufacturing organization in Bloomington, IN, received an FDA Form 483 citing significant deficiencies. These included inadequate re-qualification of sterilization processes and documentation for sterile drug products, non-contemporaneous batch record entries, and the absence of a written stability testing program. The firm also failed to thoroughly review batch failures and implement a corrective action plan for recurring complaints of leaking vaccine containers.