# FDA 483 - Safecor Health, LLC - June 12, 2026

Source: https://www.keypedia.com/records/483/safecor-health-llc/5752cc3e-3c02-49f1-a1e0-873183eaaa55

> FDA 483 for Safecor Health, LLC on June 12, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safecor Health, LLC
- Inspection Date: 2026-06-12
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: 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.

## Related Documents

- [483 - 2016-06-30](https://www.keypedia.com/records/483/safecor-health-llc/cd99bf24-180f-48d6-8c0c-2473de151284)
- [483 - 2018-02-02](https://www.keypedia.com/records/483/safecor-health-llc/b5c66512-b5a2-471f-acc9-d77049bd052b)
- [EIR - 2018-02-02](https://www.keypedia.com/records/eir/safecor-health-llc/68fe04cb-494f-497e-a1e3-ded7842780ef)
- [483 - 2023-09-01](https://www.keypedia.com/records/483/safecor-health-llc/3a126c11-9649-4f0a-9284-c31cdbe70fda)
- [WARNING_LETTER - 2023-03-16](https://www.keypedia.com/records/warning_letter/safecor-health-llc/8521ff6d-bf16-4bb3-ae52-3f065864a452)

## Related Officers

- [Anna M. Spiros](https://www.keypedia.com/people/anna-m-spiros/13e6a69c-d3d5-431c-9895-0df9b86691b7)

Company: https://www.keypedia.com/companies/safecor-health-llc/0d429e90-aad6-4d51-bff3-4a4995282dae

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22