FDA 483 - Ferndale Laboratories, Inc. - February 27, 2026

An FDA inspection of Ferndale Laboratories, Inc. in Ferndale, MI, from February 23-27, 2026, revealed a significant quality control deficiency. The firm failed to verify the identity of each component of drug products by not conducting identity tests on all containers of a raw material used in manufacturing. This lapse led to the release and shipment of drug products made with unverified components.