# FDA 483 - Safecor Health, LLC - March 16, 2023

Source: https://www.globalkeysolutions.net/records/483/safecor-health-llc/aa9469fc-f254-46e1-a1c8-71d37c281328

> FDA 483 for Safecor Health, LLC on March 16, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safecor Health, LLC
- Inspection Date: 2023-03-16
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Safecor Health, LLC, a human drug product manufacturer and repackager in Woburn, MA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to thoroughly investigate out-of-specification results and customer complaints, maintain adequate line clearance, and properly clean and maintain equipment. Additionally, issues were noted with documentation practices and the validation of purified water USP supplier analyses.

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## Related Officers

- [Sean R. Marciisin](https://www.globalkeysolutions.net/people/sean-r-marciisin/ca11c971-32fb-4786-9e30-9d579d546bce)
- [Investigator](https://www.globalkeysolutions.net/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)

Company: https://www.globalkeysolutions.net/companies/safecor-health-llc/b344a811-7abf-44a5-8723-cd4a89227440

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7