Analytical Quality Control News

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter following an inspection conducted in September 2025. The contract testing laboratory in question analyzed active pharmaceutical ingredients (APIs) and intermediates for compliance with regulatory standards for the U.S. market.

At the end of January, the U.S. Food and Drug Administration (FDA) published a new Warning Letter. The document, addressed to a Turkish OTC manufacturer, specifically criticizes the testing of incoming components and release testing.

USP recently published a draft revision of Chapter <1032> Design and Development of Biological Assays, which will be available for comment until the end of January. This chapter is part of 5 USP chapters that deal with the topic of bioassasys.

In November, the FDA issued a warning letter to a manufacturer of topical products in France. In addition to inadequate testing of components used, e.g. for ethylene or diethylene glycol, the warning letter also includes a whole series of other deviations.