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

Source: https://www.keypedia.com/records/483/safecor-health-llc/87793694-ecd6-43d9-ada1-0ab7c5816453

> 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: New England District Office
- Summary: During an inspection conducted from March 7-16, 2023, the FDA identified significant deficiencies at Safecor Health, LLC, a human drug product manufacturer and repackager in Woburn, MA. The firm received a Form FDA 483 outlining six observations related to its compliance with Current Good Manufacturing Practices (CGMP).

Key violations include a repeat observation (from 2015) regarding the failure to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) stability results for repackaged drug products like Methadone and Phenytoin. The inspection also found inadequate line clearance procedures, evidenced by unidentified tablets and incorrect packaging materials in active production areas, which previously led to customer complaints about mislabeled products.

Further issues involved improper cleaning and maintenance of equipment, with residue found on "clean" machinery and incomplete maintenance logs, alongside overdue preventive maintenance tasks. Documentation practices were also criticized; the firm failed to follow its own procedures, with partially completed CGMP forms found in the trash, use of whiteout, and uncontrolled blank forms. Another repeat observation (from 2017) highlighted the firm's failure to periodically validate purified water USP supplier certificates of analysis. Finally, customer complaint records were deficient, lacking documented follow-up investigations.

To address these findings, Safecor Health, LLC is required to implement comprehensive corrective and preventive actions, including improving investigation processes, enhancing line clearance and equipment maintenance protocols, reinforcing documentation adherence, validating raw material suppliers, and ensuring complete complaint handling. These actions are crucial for ensuring the safety, identity, strength, quality, and purity of their drug products.

## 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)

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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