FDA WARNING_LETTER - Fresenius Kabi Oncology Ltd - January 18, 2013

This FDA Warning Letter, dated July 1, 2013, addresses Fresenius Kabi Oncology Ltd's pharmaceutical manufacturing facility in Kalyani, India, following a January 2013 inspection. The inspection revealed significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs), rendering their APIs adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Data Integrity Issues:** Unofficial testing ("test," "trial," "demo" injections) was conducted, with only passing results reported. Out-of-specification (OOS) results were ignored or retested without justification. Electronic data management permitted unauthorized alterations or deletions, raising serious concerns about data reliability and the effectiveness of the quality system. Senior management initially claimed unawareness of these issues. 2. **Batch Blending:** The firm combined API batches that failed impurity specifications with passing batches to meet final specifications. Management acknowledged this practice, which occurred to resolve impurity issues after process modifications. This indicates poor quality governance. 3. **Incomplete Laboratory Records:** Raw data chromatograms labeled "test" and "demo" were found, injected prior to official samples used for batch release, indicating that not all necessary test data was included in compliance records. 4. **Inadequate OOS Procedures:** The laboratory's written procedures for retesting OOS results were