# FDA WARNING_LETTER - Nowrez & Ismail Shukri Company - July 11, 2024

Source: https://www.globalkeysolutions.net/records/warning_letter/nowrez-ismail-shukri-company/62a7739d-a7e3-4618-8473-8d734e838004

> FDA WARNING_LETTER for Nowrez & Ismail Shukri Company on July 11, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Nowrez & Ismail Shukri Company
- Inspection Date: 2024-07-11
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On July 11, 2024, the FDA issued a Warning Letter to Nowrez & Ismail Shukri Company, an OTC drug manufacturer in Amman, Jordan, following a review of records requested on September 12, 2022, and February 26, 2024. The FDA found significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Violations include:
1.  **Failure to conduct adequate finished drug product testing (21 CFR 211.165(a))**: Certificates of Analysis (COAs) for products like Isopropyl Rubbing Alcohol lacked appropriate assay and microbiological testing for active ingredient content.
2.  **Failure to establish an adequate stability testing program (21 CFR 211.166(a))**: Provided stability data for Isopropyl Rubbing Alcohol did not demonstrate ongoing chemical and microbiological testing to support the stated expiry period.
3.  **Failure to test incoming components for identity, purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2))**: The firm did not test active ingredients, such as isopropyl alcohol, for methanol, relying solely on supplier COAs, which is insufficient.

The FDA recommends engaging a qualified CGMP consultant to perform a comprehensive six-system audit and evaluate corrective actions before resuming

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.globalkeysolutions.net/companies/nowrez-ismail-shukri-company/03c1efdb-0e41-44c2-a092-be812718215b

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c