483
Femcap IncFDA 483 - Femcap Inc - August 08, 2025
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
Femcap, Inc. in Warren, MI, was inspected by the FDA, revealing significant deficiencies in their quality system. The inspection found that the firm lacked adequate procedures for supplier control, incoming product acceptance, and the management of nonconforming products. These issues indicate a serious breakdown in ensuring product quality and compliance.
- Office
- Detroit District Office
- Person
Open in Dashboard
ID · 4b5c8cf7-c728-4855-a02d-a8780721aa2e