# Safecor Health, LLC – FDA 483, Mar 16, 2023

Source: https://www.keypedia.com/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: Division of Northeast Imports 
- 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.keypedia.com/people/sean-r-marciisin/ca11c971-32fb-4786-9e30-9d579d546bce)
- [Investigator](https://www.keypedia.com/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)
- [Vascular Neurologist Investigator](https://www.keypedia.com/people/sean-d-duke/ea627ffa-8e7c-4c2e-a9e0-31a41fe44ccf)
- [President at Genpact](https://www.keypedia.com/people/damon-a-growl/b2827f8c-e454-4db3-9285-07d11b964d5a)
- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94