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# CGMP Violations at Essnd Global
- URL: https://www.fdaweb.com/cgmp-violations-at-essnd-global/
- Published: 2020-02-25T12:00:00.000Z
- Updated: 2026-09-14T16:04:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146166

A 9/9-9/13/19 FDA inspection at the Essnd Global drug manufacturing facility in Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/14 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/essnd-global-595850-02142020?ref=fdaweb.com) says specific violations were:

· failing to perform, 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, and for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing, as necessary;

· failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failing to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals; and

· failing to establish an adequate quality control unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. 

FDA says the firm did not respond to the inspection observations. The letter reminds Essnd that it is responsible for the quality of drugs it produces as a contract facility regardless of agreements in place with product owners.

The agency strongly recommends that the company retain a qualified consultant to assist it in meeting CGMP requirements if it intends to continue manufacturing products for the U.S. market. It also recommends that the consultant perform a comprehensive audit of the company’s entire operation for CGMP compliance and efficacy of Essnd’s corrective and preventive actions before it seeks resolution of its compliance status with FDA.

Essnd was placed on an import alert on 1/31\. It was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion of the actions.