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# CGMP Violations at Jabones y Productos Especializados
- URL: https://www.fdaweb.com/cgmp-violations-at-jabones-y-productos-especializados/
- Published: 2018-09-18T12:00:00.000Z
- Updated: 2026-09-15T00:32:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142374

A 3/20-3/23 FDA inspection at the Jabones Y Productos Especializados drug manufacturing facility in Jalisco, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/5 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm619968.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 validate and establish the reliability of component suppliers’ test analyses at appropriate intervals;
- 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; 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.

“In your response, you acknowledged the significance of the CGMP observations,” the letter says. “However, you provided limited corrective actions and did not provide sufficient detail and evidence to support that your proposed corrective actions will bring your operations and distributed drug products into compliance with CGMP. In your response you also stated that you will stop manufacturing \[a redacted product or products\] for the U.S. market.”

FDA says that if the firm resumes manufacturing drugs for the U.S. market, it strongly recommends engaging a qualified consultant to conduct a comprehensive audit and assist with remediating operations. The company was placed on an import alert 8/1\. And it 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.