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# CGMP, Other Violations at Furley Bioextracts
- URL: https://www.fdaweb.com/cgmp-other-violations-at-furley-bioextracts/
- Published: 2021-09-22T12:00:00.000Z
- Updated: 2026-09-14T17:15:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150195

FDA says a review of records submitted by Furley Bioextracts SDN BHD, Selangor, Malaysia, a manufacturer of over-the-counter drug products, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs, along with a misbranded unapproved new drug. A 9/13 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/furley-bioextracts-sdn-bhd-614592-09132021?ref=fdaweb.com) says specific CGMP violations are: 

- 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, before release;
- failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality; and
- failing to assure that the drug product bore an expiration date that was supported by appropriate stability testing.

The letter also says the company’s PainFix Relief Gel is a misbranded unapproved new drug.

The firm’s quality systems are inadequate, FDA says, and it recommends that Furley engage a qualified consultant to perform a comprehensive audit of its entire operation for CGMP compliance and evaluate the completion and efficacy of its corrective and preventive actions before the firm pursues resolution of its compliance status with the agency.

Furley was told to respond with a list of steps it has taken to correct the violations and prevent their recurrence, with a timetable for completing the corrections.