483
Safecor Health, LLCSafecor Health, LLC – FDA 483, Jun 12, 2026
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.
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