FDA 483 - Baxter Pharmaceuticals India Pvt Ltd - January 27, 2023

From January 19-27, 2023, the FDA inspected Baxter Pharmaceuticals India Pvt Ltd, a drug manufacturer in Ahmedabad, Gujarat, India. The inspection revealed nine observations.

**Observation 1: Failure to thoroughly review unexplained discrepancies and batch failures.** * The automatic visual inspection machine failed to reject all defective vials using existing commercial recipes, yet these recipes continued to be used for US-bound batches until October 13, 2022. No non-conformance investigation was opened to assess the impact on previously released product or the continued use of the equipment. * An Out-of-Specification (OOS) investigation for sub-visible particulate matter was inadequate. The identified root cause (rusted scissors) was not scientifically justified, as other lots cut with the same scissors passed, and the analyst continued using them. * No routine identification of particulate matter from visual inspection was performed to evaluate sources. * An OOS investigation for an unknown impurity was invalidated without scientific justification, and laboratory incidents during repeat analyses were not logged or investigated per SOPs. * Repeated Laboratory Incidence Reports (LIRs) for pipetting errors during BET analyses did not lead to further CAPA actions unless associated with the same analyst. Previous communications to the FDA regarding BET OOS reductions did not consider LIR data. * Two BET OOS investigations with unscientific root causes had not been further evaluated since October 2022. * Sixteen