FDA 483 - Baxter Healthcare Corporation - September 29, 2025

An FDA inspection conducted from September 22-29, 2025, identified significant deficiencies at the inspected firm, indicating non-compliance with current Good Manufacturing Practices (cGMP) regulations. The inspection highlighted five main observations. Firstly, the firm failed to thoroughly investigate unexplained discrepancies, specifically a foreign body (polypropylene resin) found in plastic pour bottles, without expanding the investigation to all potentially affected distributed products. Secondly, laboratory controls were found inadequate, lacking scientifically sound sampling and test procedures, evidenced by the release of a batch despite initial out-of-specification assay results without proper justification for a revised test plan. Thirdly, data integrity was compromised, as raw laboratory test data backups were not consistently exact, complete, or secure from alteration or loss. Fourth, equipment maintenance was insufficient, with rust observed in a glass bottle filling line, posing a contamination risk. Lastly, building maintenance was poor, specifically a failed seal in an ISO-classified cleanroom, allowing potential contamination entry. These observations require the firm to implement comprehensive corrective actions to ensure compliance with regulatory standards and maintain product safety and quality.