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# CGMP Violations at Hong Kong’s Luen Wah Medicine
- URL: https://www.fdaweb.com/cgmp-violations-at-hong-kongs-luen-wah-medicine/
- Published: 2018-04-17T12:00:00.000Z
- Updated: 2026-09-14T23:59:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141237

A 9/25-9/28/17 FDA inspection at Luen Wah Medicines, Hong Kong, found significant violations of current good manufacturing practice regulations (CGMP) for finished pharmaceuticals, according to a 4/6 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm604456.htm?ref=fdaweb.com). Specific violations cited in the letter were: 

- failing to perform, 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, prior to release, and for each batch of drug product to be free of objectionable microorganisms, appropriate laboratory testing, as necessary;
- failing to conduct at least one test to verify the identity of each component of a drug product and failing to establish the reliability of component supplier analyses on which the firm relies in lieu of certain tests through appropriate validation of the supplier’s test results at appropriate intervals;
- failing to ensure that a drug product bears an expiration date that is supported by appropriate stability testing; and
- failing to establish adequate written procedures for production and process control designed to assure that the drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess.

“We acknowledge that your firm was working with a consultant during the inspection,” FDA says. “However, based upon the nature of the violations we identified as your firm, we strongly recommend engaging a consultant qualified to assist your firm in meeting CGMP requirements.” The company was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.