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# CGMP Violations at Malaysia’s Luen Fook Medicine
- URL: https://www.fdaweb.com/cgmp-violations-at-malaysias-luen-fook-medicine/
- Published: 2019-04-16T12:00:00.000Z
- Updated: 2026-09-15T01:20:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143874

A 12/10-12/14/18 FDA inspection at Luen Fook Medicine, Johor, Malaysia, found significant violations of current good manufacturing practice (CGMP) regulations and manufacturing of an unapproved new drug. A 4/4 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm635686.htm?ref=fdaweb.com) says specific violations were: 

- failing 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;
- failing to establish written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess, and failing of the firm’s quality control unit to review and approve the procedures, including any changes;
- failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements; and
- failing 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.

The letter says that similar observations were cited in a 5/2015 inspection and the firm proposed specific remediation for those observations in its response. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” FDA says.

The agency recommends that Luen Fook retain a qualified consultant to perform a comprehensive audit of its entire operation for CGMP compliance, assist the firm in complying, and evaluate the completion and efficacy of corrective and preventive actions before the company pursues resolution of its compliance status with FDA.

In addition, the letter says that the firm’s African Sea-Coconut Sore Throat Syrup is considered to be a drug and is not formulated or labeled in accordance with conditions in the tentative final monograph for oral health care products for over-the-counter human use. It also says that FDA is not aware of any adequate or well-controlled clinical trials supporting a determination that the syrup is generally recognized as safe and effective for its labeled indication.

Luen Fook was placed on an import alert 3/29\. The company was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.