FDA issues Warning letter to Jordanian OTC drug Manufacturer

The U.S. FDA issued a Warning Letter on July 11, 2024, to a Jordanian OTC drug manufacturer, Nowrez & Ismail Shukri Company, publicly released on August 13, 2024. The letter cites several CGMP violations:

• Laboratory Testing: The company failed to conduct essential finished product tests on its OTC drugs, with Certificates of Analysis missing key assays, including active ingredient content and microbiological testing.
• Stability Testing: The company lacked a sufficient stability testing program to support the assigned expiration dates of its products.
• Raw Material Testing: The company did not adequately test the identity of incoming raw materials, specifically failing to test isopropyl alcohol for methanol contamination, relying solely on the supplier's COA.

As a result, the FDA placed the company on Import Alert 66-40, preventing its products from entering the U.S. market until compliance is achieved. The company may need to hire a CGMP consultant to address these violations.