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# CGMP, Other Violations at AMMD Labs
- URL: https://www.fdaweb.com/cgmp-other-violations-at-ammd-labs/
- Published: 2019-05-28T12:00:00.000Z
- Updated: 2026-09-15T01:29:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144197

A 9/10-9/14/18 FDA inspection at AMMD Labs, Pompano Beach, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other issues. A 5/2 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ammd-labs-llc-568180-05072019?ref=fdaweb.com) says the violations 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 appropriate testing as necessary for each batch of drug product required to be free of objectionable microorganisms;
- failing to establish adequate 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;
- failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates; and
- failing to establish a 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, including drug products manufactured, processed, packed, or held under contract by another company, and failing to establish adequate written responsibilities and procedures applicable to the quality control unit.

The letter says significant inspection findings indicate that the firm’s quality unit is not fully exercising its authority and/or responsibilities and recommends that the company engage a qualified third party to perform a comprehensive audit of its entire operation for CGMP compliance and evaluate the effectiveness of the company’s corrective and preventive actions.

FDA also says that although the company purports that its products are marketed as cosmetics, their labeling contains claims that make them drugs under the law and regulations, but there is no approved application or compliance with a monograph.

AMMD was told to respond with a list of specific steps taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.