483
Safecor Health, LLCFDA 483 - Safecor Health, LLC - June 12, 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
Safecor Health, LLC, a repackager/relabeler in Columbus, OH, was cited for significant deficiencies in its quality control system during an FDA inspection. The firm failed to thoroughly investigate unexplained discrepancies and batch failures, particularly for reprocessed drug products, and did not adequately track or trend these events. Additionally, batch production and control records for reprocessing events were found to be incomplete and inaccurate.
- Person
Open in Dashboard
ID · 5752cc3e-3c02-49f1-a1e0-873183eaaa55