# FDA 483 - Safecor Health, LLC - October 28, 2025

Source: https://www.keypedia.com/records/483/safecor-health-llc/ebf50aad-2528-425c-9c76-5c89bfbbeae9

> FDA 483 for Safecor Health, LLC on October 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safecor Health, LLC
- Inspection Date: 2025-10-28
- Product Type: drugs
- Office Name: New England District Office
- Summary: Safecor Health, LLC, a manufacturer and repackager in Woburn, MA, was cited for significant deficiencies in its quality control unit during an FDA inspection from October 22-28, 2025. The firm failed to consistently follow its own written procedures for Corrective and Preventative Action (CAPA) management, Deviation management, and Out-of-Specification (OOS) investigations. These issues primarily concerned timely closure and proper documentation of extensions, indicating a systemic breakdown in maintaining control over critical quality processes.

## Related Documents

- [483 - 2011-03-07](https://www.keypedia.com/records/483/safecor-health-llc/208db32a-c718-4985-be89-f066934769ed)
- [483 - 2015-10-27](https://www.keypedia.com/records/483/safecor-health-llc/b3360ec2-3446-4cfb-b296-cb9291495b6c)
- [483 - 2017-10-19](https://www.keypedia.com/records/483/safecor-health-llc/3cd0a460-a2f1-413b-b3fa-259262732805)
- [483 - 2023-03-16](https://www.keypedia.com/records/483/safecor-health-llc/aa9469fc-f254-46e1-a1c8-71d37c281328)
- [483 - 2024-06-24](https://www.keypedia.com/records/483/safecor-health-llc/96d351c8-f88d-4582-8b67-f4ef999c675d)

## Related Officers

- [Ogechi C. Nna](https://www.keypedia.com/people/ogechi-c-nna/59452184-8197-4ba6-bf1d-78a7e003ef2c)

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

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144