FDA WARNING_LETTER - Yicheng Chemical Corp. - July 21, 2017

The FDA issued a Warning Letter to Yicheng Chemical Corporation following an inspection from July 17-21, 2017, identifying significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Cross-contamination risk:** Failure to package penicillin and non-penicillin drugs under appropriate conditions. The firm used the same room and non-dedicated equipment for weighing and repackaging both, posing an unacceptable risk of life-threatening allergic reactions. The FDA stated cleaning cannot substitute for proper segregation and recommended dedicated, segregated facilities with separate air handling systems and equipment for penicillin manufacturing. 2. **Inadequate Quality Unit Review:** The firm lacked repackaging batch records and the quality unit had no written procedures for API repackaging batch review, approval, and release prior to distribution. 3. **Lack of API Traceability:** The firm lacked documentation or procedures to ensure complete traceability of API from suppliers, through repackaging, and into commercial distribution.

The firm's August 4, 2017, response was deemed inadequate. The FDA strongly recommended engaging a CGMP consultant. As a result of these deviations, Yicheng Chemical Corporation was placed on Import Alert 66-40 on August 11, 2017. The FDA may withhold approval of new applications and continue to refuse admission of articles manufactured by the firm until all deviations are