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# CGMP Violations at Demark’s DermaPharm
- URL: https://www.fdaweb.com/cgmp-violations-at-demarks-dermapharm/
- Published: 2020-03-24T12:00:00.000Z
- Updated: 2026-09-14T16:08:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146399

A 9/16-9/19/19 FDA inspection at DermaPharm A/S, Farup, Denmark, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/10 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dermapharm-596662-03102020?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, before release;
- failing to conduct at least one test to verify the identity of each component of a drug product and failing to validate and establish the reliability of the component supplier’s analyses at appropriate intervals; and
- failing to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess.

The letter says that based on the violations identified at the firm, FDA recommends that DermaPharm engage a qualified consultant to perform a comprehensive audit of the company’s entire operation for CGMP compliance and assist it in meeting CGMP requirements. The consultant should also evaluate the completion and efficacy of the firm’s corrective and preventive actions before it pursues resolution of its FDA compliance status.

DermaPharm was placed on an import alert on 3/9\. It was told to respond with a list of actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion of the actions.