> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CGMP Violations in Casmara Cosmetics Inspection
- URL: https://www.fdaweb.com/cgmp-violations-in-casmara-cosmetics-inspection/
- Published: 2018-02-20T12:00:00.000Z
- Updated: 2026-09-14T23:23:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140791

A 5/29-5/31/17 FDA inspection at Casmara Cosmetics, a Valencia, Spain, drug manufacturing company, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/12 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm597084.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 prior to release;
- 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 analysis on which the firm relies in lieu of certain tests through appropriate validation of the supplier’s test results at appropriate intervals;
- failing to follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates; and
- 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.

 The letter says the firm’s responses to the agency inspection did not provide sufficient details or evidence that the firm will remediate its operations to ensure compliance with CGMP. “Based on the nature of the violations,” FDA says, “we strongly recommend engaging a consultant … to assist your firm in meeting CGMP requirements.” FDA also expresses concerns about labeling for the firm’s over-the-counter products. It placed the company on import alert 10/12/17.

Casmara 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.