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

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