FDA EIR - Zhejiang Haisen Pharmaceutical Co., Ltd. - April 11, 2018

Zhejiang Haisen Pharmaceutical Co., Ltd. underwent an FDA inspection from April 6-11, 2018, primarily to follow up on corrective actions from a previous "Official Action Indicated" classification. The inspection was conducted under CPGM 7368.001 and ICH Q7 guidelines for active pharmaceutical ingredient (API) manufacturers. A 2-item Form FDA 483 was issued at the conclusion of the inspection. Key observations included raw data inconsistencies with information submitted in the Vendor Master File (VMF), specifically regarding accuracy and robustness data for an API. Additionally, significant issues were found in the firm's complaint handling system, which lacked proper procedures for identifying quality-related complaints, documenting oral complaints, and adequately investigating reported issues. Further data integrity concerns arose from improperly integrated peaks in submitted data that were not updated to the FDA, and numerous unexplained modifications in HPLC system audit trails, compounded by the firm providing a blank audit trail file. Management acknowledged these deficiencies and committed to submitting a written response within 15 business days, outlining corrective actions to address the data integrity and complaint handling violations.