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# Dibar Nutricional CGMP Violations
- URL: https://www.fdaweb.com/dibar-nutricional-cgmp-violations/
- Published: 2021-03-16T12:00:00.000Z
- Updated: 2026-09-14T16:50:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148889

FDA says its review of records supplied by Dibar Nutricional, a Morelia, Michoacan, Mexico, manufacturer of over-the-counter (OTC) drugs, determined 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/dibar-nutricional-s-de-rl-de-cv-610444-03102021?ref=fdaweb.com) says the specific violations are: 

- failing to conduct at least one test to verify the identity of each component of a drug product;
- failing to perform, for each batch of a 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 establish and follow an adequate written testing program designed to access the stability characteristics of drug products; and
- failing to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance.

FDA says it strongly recommends that Dibar engage a qualified consultant to perform a comprehensive audit of its entire operation for CGMP compliance, assist the firm in meeting CGMP requirements for drug products, and evaluate the completion and efficacy of its corrective and preventive actions before Dibar pursue resolution of its compliance stats with FDA.

The agency placed the firm’s drug products on an import alert on 11/6/20\. The company was told to respond with a list of specific actions taken to address the violations and prevent their recurrence, with a schedule for completing the actions.