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# CGMP Issues at Mexico’s Prosana Distribuciones
- URL: https://www.fdaweb.com/cgmp-issues-at-mexicos-prosana-distribuciones/
- Published: 2018-01-02T12:00:00.000Z
- Updated: 2026-09-14T23:09:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140390

A 3/6-3/9/17 FDA inspection at Prosana Distribuciones SA de CV, Mexico City, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 12/18/17 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590494.htm?ref=fdaweb.com) says that 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;
- 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 company relies in lieu of certain tests through appropriate validation if the supplier’s test results at appropriate intervals;
- failing to prepare batch production and control records for each batch of drug product that include complete documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, including a statement of the actual yield, and a statement of a percentage of theoretical yield at appropriate phases of processing; and
- failing to establish adequate written procedures for production and process control designed to assure that drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess.

The firm’s response to the inspection observations was inadequate, the letter says, because it did not provide sufficient evidence of corrective actions to bring its operations into compliance with CGMP. FDA recommended that the company undertake a comprehensive and global assessment to ensure that its systems and processes and ultimately its drug products conform to FDA requirements. It recommended use of a qualified consultant to assist it in meeting CGMP requirements.

The agency also says that claims on the label for its Bicaruvas establish that it is a drug under the Federal Food, Drug, and Cosmetic Act and as an antacid would be subject to the Final Monograph for Antacid Drug Products for Over-the-Counter Use. However, it says, the product is not formulated in accordance with the final monograph.

Further, the letter says, Bicaruvas is misbranded because some information required on the labeling is not in both English and Spanish. And neither the outer carton nor the individual packets contain a lot or control number and expiration date.

The company was placed on import alert 7/12/17.

Prosana was told to respond with steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.