The U.S. Food and Drug Administration (FDA) has issued a Form 483 to Jiangsu Hengrui Medicine (SHA: 600276), a leading drug manufacturer in China. The document, which spans eight pages, details several compliance issues observed during an inspection. Notably, it mentions an incident where an employee attempted to divert inspectors away from the office waste area upon request, while another was seen attempting to dispose of documents.
The discarded documents, as noted by the inspectors, included critical records such as batch records, validation protocols, reports, and standard operating procedures. Discrepancies were found between these discarded documents and the official records, particularly in terms of production data. Other observations included inadequate management of active ingredients marked for destruction and insufficient controls over critical documents like production batch records and labeling.
A Form 483 is a notification issued by the FDA to a company’s management following an inspection, highlighting potential violations of the U.S. Food, Drug, and Cosmetic (FD&C) Act. It typically precedes a discussion between the FDA and the company’s senior management, who are expected to provide a written response detailing a corrective action plan. The issuance of a Form 483 does not represent a definitive conclusion that the FD&C Act has been violated.- Flcube.com
