FDA 483 - Sichuan Huiyu Pharmaceutical Co., Ltd. - July 26, 2022

An FDA inspection conducted on July 26, 2022, at Sichuan Huiyu Pharmaceutical Co., Ltd. in Neijiang, Sichuan, China, resulted in the issuance of a Form FDA 483. This document outlines significant observations indicating deviations from current Good Manufacturing Practices (GMP) for sterile drug manufacturing. Two primary observations were noted. First, the firm's laboratory controls were found to be inadequate. Specifically, system suitability and sample injections for assays, such as related substances and assay determination for specific injections, were not executed in a continuous sequence, contrary to scientifically sound test procedures designed to ensure drug product quality and purity. Second, the inspection identified deficiencies in the materials system, particularly regarding supplier qualification. The Quality Assurance Unit's supplier controls were insufficient to guarantee that active ingredients and raw materials met established acceptance criteria. For instance, the firm qualified critical material suppliers by testing only a single batch, whereas industry best practice requires testing at least three batches for robust qualification. Furthermore, the firm lacked clear instructions for systematically comparing its own test results with supplier-provided Certificates of Analysis. These observations require the company to implement comprehensive corrective and preventive actions to ensure compliance with regulatory standards and safeguard product quality and patient safety. The FDA expects the firm to address these issues to prevent recurrence.