Fresenius Kabi Oncology Limited – FDA Warning Letter, May 24, 2017

The FDA issued a Warning Letter to Fresenius Kabi Oncology Ltd following a May 15-24, 2017 inspection of their Kalyani, India drug manufacturing facility. The letter identifies significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Inadequate Out-of-Specification (OOS) Investigations:** The firm failed to adequately investigate and document OOS results, lacking scientific justification to invalidate initial OOS results. Examples cited include investigations OOS/2015/098 and OOS 50989, where OOS results were invalidated without conclusive evidence of laboratory error or expansion to manufacturing root causes. The firm's OOS procedure (036/?/QS/QA) was found deficient for permitting analysts to abort chromatographic runs based on "online monitoring" and for not ensuring investigations proceed to Phase 2 when laboratory error is inconclusive. Approximately 248 instances of aborted sequences were documented. 2. **Unsound Test Procedures:** Test methods were not robust. Examples include an OOS assay result for an intermediate API (OOS/2015/037) attributed to autosampler temperature, and an OOS assay in stability batches of API (OOS/2015/124) attributed to vial brand interaction. The firm's corrective actions were deemed