FDA issues Warning to Jordanian OTC Manufacturer

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a manufacturer of over-the-counter (OTC) drug products in Jordan. The document dated 11 July 2024 was published on the FDA website on 13 August 2024.

The Warning Letter outlines several violations of Current Good Manufacturing Practices (CGMP):

• Laboratory Testing for Drug Products: The FDA noted that the company failed to conduct appropriate finished drug product testing on its OTC products. Specifically, the Certificates of Analysis (COA) provided by the company were missing critical tests, such as assays for active ingredient content and microbiological testing. This lack of scientific evidence means the company could not ensure that its drug products met the necessary specifications before release to consumers.
• Stability Testing: The FDA also pointed out that the company lacked an adequate written stability testing program to assess the long-term stability of its drug products. The available data were insufficient to support the expiration dates assigned to the products.
• Laboratory testing of raw materials: The records and information provided did not demonstrate adequate testing of the identity of incoming components used in manufacturing the OTC drug products. Specifically, the company did not test the active ingredient, isopropyl alcohol, for methanol contamination, relying solely on the supplier's Certificate of Analysis (COA) for identity verification.

As a result, the FDA placed the company on Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"), restricting their products from entering the U.S. market until these issues are resolved. The company is urged to promptly correct these violations and may need to hire a CGMP consultant to ensure compliance. Failure to address the violations could lead to continued restrictions and further regulatory actions.

More information can be found in the Warning Letter to Nowrez & Ismail Shukri Company on the FDA's Website.