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# Nowrez & Ismail Shukri CGMP Violations
- URL: https://www.fdaweb.com/nowrez-ismail-shukri-cgmp-violations/
- Published: 2024-08-13T12:00:00.000Z
- Updated: 2026-09-14T14:38:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157558

An FDA review of records submitted by Nowrez & Ismail Shukri Company in Amman, Jordan, identified significant violations of current good manufacturing practice (CGMP) regulations in its production of over-the-counter finished drugs. A just-released 7/11 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nowrez-ismail-shukri-company-682810-07112024?ref=fdaweb.com) says specific violations were:

- failure 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, before release;
- failure to establish and follow an adequate written testing program to assess the stability characteristics of drug products; and
- failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.

FDA says that if the company intends to resume manufacturing drugs for the U.S. market, it should engage a qualified consultant to assist it in meeting CGMP requirements. FDA placed the firm on a 7/3 Import Alert.

The letter says Shukri should correct any violations promptly and should respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.