Baxter Healthcare Corporation – FDA Warning Letter, Jan 27, 2023

The FDA inspected Baxter Pharmaceuticals India Pvt. Ltd. from January 19-27, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate unexplained discrepancies, specifically regarding endotoxin testing and their 100% automated visual inspection system. Previous citations for similar issues in May 2022 were not adequately addressed, and a retrospective assessment by a third-party consultant was incomplete. The firm lacked assurance that sterile injectable drug batches were free from visible particulates. 2. **Inadequate Cleaning Procedures (21 CFR 211.67(b)):** White spots, identified as residual product, were found in a bulk solution holding tank documented as clean, exceeding post-cleaning residue limits. The firm's response regarding visual inspection and impact assessment was deemed inadequate. 3. **Inadequate Production and Process Controls (21 CFR 211.100(a) and (b)):** The visual inspection program for sterile injectable drug products did not assure product quality, particularly regarding particulate matter. The firm's proposed corrective actions for manual visual inspection were insufficient. 4. **Inappropriate Equipment Design and Maintenance (21 CFR 211.63):** Damaged equipment