FDA WARNING_LETTER - Tianjin Zhongan Pharmaceutical Co., Ltd. - September 27, 2013

On June 10, 2014, the FDA issued a Warning Letter to Tianjin Zhongan Pharmaceutical Co., Ltd. following a September 23-27, 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. **Inadequate Equipment Cleaning and Record Keeping:** Failure to properly clean equipment (e.g., contaminated tanks labeled "clean") and maintain adequate usage records. The firm's response was deemed insufficient for not addressing the extent of the issue or committing to equipment logs. 2. **Deficient Change Control:** Failure to evaluate, document, and approve changes in production (e.g., altered manufacturing steps, unapproved equipment changes, outdated drawings). The firm's revised procedure was not applied retroactively, and compliance was not ensured. 3. **Inadequate Deviation Investigations:** Failure to properly investigate product deviations (e.g., contaminated manufacturing equipment, insufficient sample testing, untimely investigations). The firm's response lacked detail on addressing the extent of the problem.

Additional concerns included uncontrolled Certificates of Analysis (COAs) and inadequate qualification of critical production equipment, with outdated technical drawings and missing installation verification parameters.

The FDA recommended engaging a third-party CGMP consultant and emphasized the need