FDA WARNING_LETTER - Zhejiang Hisun Pharmaceutical Co., Ltd. - March 07, 2015

The FDA issued a Warning Letter to Zhejiang Hisun Pharmaceutical Co., Ltd. on December 31, 2015, following an inspection from March 2-7, 2015. The inspection identified significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API), rendering their drugs adulterated under Section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to prevent unauthorized data access/changes and ensure data integrity:** Investigators found systemic data manipulation, including routine re-testing without justification, deletion of analytical data, and disabled audit trails on HPLC systems. Examples cited include deleted HPLC data for validation stability batches and API batches, and missing raw data for customer complaints regarding subpotency and OOS impurity levels. The firm's responses regarding system suitability failures or training purposes for deleted data were deemed inadequate. 2. **Failure to conduct appropriate microbiological testing:** During the inspection, dried and cracked culture media plates were observed, compromising microbial testing. The firm's investigation was insufficient, failing to evaluate all associated batches or adequately address customer complaints of OOS microbial results.

Additionally, the firm delayed providing requested records during the inspection, which can lead to drugs being deemed adulterated under Section 501(j) of the FD&C Act.

Required corrective actions include a comprehensive investigation into data integrity deficiencies and root causes, a risk assessment