FDA 483 - Zhejiang Huahai Pharmaceutical Co., Ltd. - April 24, 2026

Between April 13 and April 24, 2026, the U.S. Food and Drug Administration (FDA) conducted an inspection of the facility associated with FEI 3003999190, managed by Linda Lin, Vice President of Quality and Regulatory Affairs. This inspection resulted in the issuance of a Form 483, which outlines preliminary observations concerning potential deviations from established quality standards and safety regulations. The primary violation identified during the inspection involves the firm"s failure to document investigations into production discrepancies. Specifically, the facility did not maintain written records regarding the failure of batches or specific components to meet predetermined quality specifications. Under the federal regulatory framework for manufacturing, such investigations are mandatory to ensure that any issues affecting product integrity are identified, analyzed, and resolved. While the Form 483 does not represent a final determination of non-compliance, it requires the firm to take immediate action. The company is expected to review the observations and submit a formal response to the FDA. This response must include a detailed corrective action plan outlining how the facility will improve its documentation processes and ensure all future manufacturing failures are thoroughly investigated and recorded. Timely and effective remediation is necessary to demonstrate compliance and ensure the ongoing safety of the products manufactured at this site.