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Just recently, we reported on a Warning Letter to an American manufacturer of hand sanitizer drug products. Now another Warning Letter has been published by the U.S. Food and Drug Administration (FDA), also addressed to such products. In this case, it is about a drug manufacturer located in Puerto Rico. In addition to formal GMP violations and inadequate analytical testing, the FDA also criticizes the overall condition of the production facility.

The analysis of the Warning Letters sent out in fiscal year 2022 offers a revealing overview of what FDA inspectors find when they visit the production facilities of medicinal product manufacturers. Read more about the "Top Ten" GMP violations.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a U.S. manufacturer. Therein, the FDA once again highlights the importance of analytical testing of incoming raw materials, finished drug product testing and stability testing. In the case in question, a manufacturer of OTC drug products had been found to have significant deficiencies in these areas.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese manufacturer. The FDA blames the company in question for a whole series of GMP violations, including to identity testing, cleaning and maintenance of equipment, microbial testing and QU oversight.