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# CGMP Violations, Deviations at Mayon’s Pharmaceuticals
- URL: https://www.fdaweb.com/cgmp-violations-deviations-at-mayons-pharmaceuticals/
- Published: 2020-09-15T12:00:00.000Z
- Updated: 2026-09-14T16:28:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147652

A 2/17-2/20 FDA inspection at the Mayon’s Pharmaceuticals facility in Nagpur, Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients (API). A 9/4 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mayons-pharmaceuticals-pvt-ltd-607388-09042020?ref=fdaweb.com) says specific violations were: 

- failing to conduct at least one test to verify the identity of each component of a drug product and failing to test each component for conformity with all appropriate specifications for purity, strength, and quality;
- failing to establish 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;
- 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;
- failing to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications; and
- failing to establish adequate written procedures for cleaning equipment and its release for use in the manufacture of APIs.

FDA placed Mayon’s on an import alert 7/13\. The firm was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the corrective actions.