News
25.07.2025 - Pharmacy
July 25, 2025 - U.S. Food and Drug Administration FDA requires sampling strategies
The U.S. Food and Drug Administration (FDA) issued a so-called Warning Letter to a manufacturer of over-the-counter topical analgesics and toothpastes. Such letters are considered significant indications of regulatory priorities and monitoring trends, especially for exporting companies in the pharmaceutical industry.
According to the current newsletter of the GMP Navigator from CONCEPT Heidelberg, the FDA objected, among other things, that the company's sampling plans were not classified as representative for entire batches. In addition, there were no uniformity investigations or robust data on process qualification, which would have justified reduced sampling.
The BAV Institute supports companies in microbiological quality control and offers comprehensive consulting on the creation and evaluation of sampling plans. Our customer advisors are available for any questions.
Sources:
- www.bav-institut.de
- www.gmp-navigator.com