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# CGMP Violations in Jiangsu Meifan Records Review
- URL: https://www.fdaweb.com/cgmp-violations-in-jiangsu-meifan-records-review/
- Published: 2024-04-09T12:00:00.000Z
- Updated: 2026-09-14T14:27:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156734

FDA’s review of records submitted by Jiangsu Meifan Biotechnology Co. Ltd., a manufacturer of over-the-counter drug products in Jiangsu, China, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/3 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jiangsu-meifan-biotechnology-co-ltd-676562-04032024?ref=fdaweb.com) says specific violations were:

- failure to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release; and
- failure to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

FDA says that if the firm intends to resume manufacturing drugs for the U.S. market it should engage a qualified consultant to assist it in meeting CGMP requirements before resuming manufacturing.

Jiangsu was placed on an Import Alert on 4/1\. It was told to correct violations promptly and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.