483
Ferndale Laboratories, Inc.FDA 483 - Ferndale Laboratories, Inc. - February 27, 2026
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · a65d3b06-f9bd-4af7-b9b1-ee62e9f47189