483
ProMED Concepts, LLCFDA 483 - ProMED Concepts, LLC - March 03, 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
PROMED Concepts, LLC, a contract manufacturer in Brighton, TN, was inspected by the FDA from February 24 to March 3, 2025. The inspection revealed significant and repeat deficiencies in the firm's quality system, specifically regarding corrective and preventive action (CAPA) procedures and the handling of customer complaints. These issues indicate a systemic failure to adequately establish and maintain essential quality processes.
- Person
Open in Dashboard
ID · cb08ce4a-d1c7-4ff9-b9c7-6922824648cd