Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistNowrez & Ismail Shukri Company, a Jordan-based manufacturer of over-the-counter drug products, was cited for significant Current Good Manufacturing Practice (CGMP) violations that rendered their finished pharmaceuticals adulterated. The company failed to conduct adequate laboratory testing on finished drug products prior to release, with certificates of analysis for products like isopropyl rubbing alcohol lacking appropriate assays for active ingredient content and microbiological testing as required by 21 CFR 211.165(a). This warning followed FDA's review of records submitted in response to two separate information requests issued in September 2022 and February 2024.