# FDA 483 - Safecor Health, LLC - June 30, 2016

Source: https://www.keypedia.com/records/483/safecor-health-llc/cd99bf24-180f-48d6-8c0c-2473de151284

> FDA 483 for Safecor Health, LLC on June 30, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safecor Health, LLC
- Inspection Date: 2016-06-30
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of SAFCOR Health LLC in Columbus, OH, a drug repackager, revealed two significant observations. The firm failed to thoroughly investigate product recalls and expand evaluations to other affected lots. Additionally, the company did not adequately validate cleaning methods for equipment and had issues with water system bioburden testing.

## Related Documents

- [EIR - 2018-02-02](https://www.keypedia.com/records/eir/safecor-health-llc/68fe04cb-494f-497e-a1e3-ded7842780ef)
- [483 - 2018-02-02](https://www.keypedia.com/records/483/safecor-health-llc/b5c66512-b5a2-471f-acc9-d77049bd052b)
- [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

- [Investigator ](https://www.keypedia.com/people/lindsey-schwierjohann/3608e7c0-5bb9-49f0-844d-ddd6f6724fdb)

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