# FDA 483 - Safecor Health, LLC - February 02, 2018

Source: https://www.globalkeysolutions.net/records/483/safecor-health-llc/b5c66512-b5a2-471f-acc9-d77049bd052b

> FDA 483 for Safecor Health, LLC on February 02, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safecor Health, LLC
- Inspection Date: 2018-02-02
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of SAFCOR Health LLC, a repackager of single unit dose oral solids and liquids in Columbus, OH, revealed significant deficiencies. The firm failed to complete investigations within required timeframes, employees did not wear appropriate protective apparel during repackaging, and the facility lacked suitable construction features to ensure proper gowning and prevent contamination. These issues indicate a lack of adherence to quality control procedures and good manufacturing practices.

## Related Documents

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

## Related Officers

- [Ucheabuchi C. Chudi-nwankwor](https://www.globalkeysolutions.net/people/ucheabuchi-c-chudi-nwankwor/18b01d08-3cfd-4ace-97b2-5f54b6427661)
- [Andrew J. Barrowcliff](https://www.globalkeysolutions.net/people/andrew-j-barrowcliff/5dd49407-9028-4c84-9e86-3f0b6239538e)

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

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