Tuesday, 12 March 2024 9 .00 - 16.45 h
At the beginning of January, the U.S. Food and Drug Administration (FDA) has published two new Warning Letters to companies registered as a manufacturer of over-the-counter (OTC) drug products in the United States.
In both cases, following a review of records provided by the companies upon FDA's request, the following CGMP violations are mentioned:
The key point is that it could not be demonstrated that each shipment of each lot of the incoming components were tested at high-risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination. In particular, the identity testing for these components include a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of DEG or EG.
Both firms were already placed an Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs").
In the Warning Letters, the FDA provides a list of measures that must be fulfilled and reported to the FDA, including the following:
There have been numerous similar cases in recent months, also relating to the testing of DEG and EG. You can find examples in our news archive: