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

Source: https://www.keypedia.com/records/483/safecor-health-llc/04372442-21bc-4c89-b6f9-da63f1285a54

> 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
- Summary: During an FDA inspection conducted from October 22 to October 28, 2025, the firm received an FDA Form 483 citing significant issues related to its quality control unit and adherence to established procedures. The primary observations indicate a systemic failure to consistently follow written protocols governing critical quality management processes. Specifically, the firm did not adequately adhere to its Standard Operating Procedure for Corrective and Preventative Action (CAPA) Management. Multiple CAPA records, including one for a customer complaint regarding a repackaged drug product, showed instances where extensions were not filed timely or were requested beyond the target due dates, contrary to the firm's own SOP. Furthermore, the inspection revealed non-compliance with the written procedures for Deviation Management, where a deviation related to a line clearance failure exceeded its target closure date without a filed extension. Similar issues were noted regarding Out-of-Specification (OOS) investigations; an OOS workflow was closed beyond the specified timeframe without documented justification, violating another internal procedure. These observations highlight that the responsibilities and procedures applicable to the quality control unit were not fully followed, indicating potential deficiencies in the firm's Current Good Manufacturing Practices (cGMP) compliance. The firm is expected to promptly address these observations by implementing robust corrective actions to ensure consistent adherence to its established quality systems and regulatory requirements under the Federal Food, Drug and Cosmetic Act.

## Related Documents

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- [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