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# CGMP Violations Found in Yusef Labs Inspection
- URL: https://www.fdaweb.com/cgmp-violations-found-in-yusef-labs-inspection/
- Published: 2017-06-06T12:00:00.000Z
- Updated: 2026-09-14T22:27:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138862

A 5/23-5/26/16 FDA inspection at Yusef Manufacturing Laboratories found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/25 Warning Letter from the agency’s Los Angeles District Office. Specific violations noted in the letter were: 

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failing to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures;
- 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 and freedom from objectionable microorganisms, prior to release;
- failing to test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality; and
- · failing to establish and follow adequate written procedures for production and process control designed to assure that drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess.

The letter reports that similar CGMP deficiencies were cited in 9/2007 and 2/2011 inspections. “Because of your failure to correct these repeat violations,” it says, “we are concerned about your firm’s fundamental understanding of regulatory requirements relating to drug manufacturing…. Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant … to assist your firm in meeting CGMP requirements.”

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