FDA 483 - Sichuan Huiyu Pharmaceutical Co., Ltd. - November 06, 2025

Sichuan Huiyu Pharmaceutical Co., Ltd., located in Neijiang, Sichuan Province, China, underwent an FDA inspection from October 27 to November 6, 2025. The inspection revealed several critical issues in the company's quality control processes and manufacturing practices.

Key violations included the quality control unit's failure to adequately investigate and address manufacturing errors. Specifically, a batch of injection products was approved despite potential contamination with glass particles due to broken vials during production. The deviation report highlighted extended processing times and numerous abnormalities in the filling process, yet the QA department concluded there was no quality risk.

Additionally, the inspection identified inadequate responses to HEPA filter leak test failures, which were not thoroughly investigated for potential impacts on product quality. The filters had exceeded allowable penetration rates, and products manufactured during this period were potentially compromised.

Moreover, the firm faced issues with endotoxin levels exceeding standards in their water system, indicating possible microbial contamination. Despite initiating investigations, the QA department failed to implement corrective and preventive actions (CAPAs) to address these systemic issues.

The FDA requires Sichuan Huiyu Pharmaceutical to conduct comprehensive internal audits, correct all violations, and establish robust quality control measures to prevent recurrence. The firm must also document all corrective actions and submit evidence of compliance to the FDA. These actions are crucial to ensure adherence to regulatory standards and safeguard product quality.