# FDA 483 - Safecor Health, LLC - March 07, 2011

Source: https://www.keypedia.com/records/483/safecor-health-llc/208db32a-c718-4985-be89-f066934769ed

> FDA 483 for Safecor Health, LLC on March 07, 2011. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safecor Health, LLC
- Inspection Date: 2011-03-07
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Safecor Health, LLC, a drug manufacturer and repackager in Woburn, MA, was cited for significant quality control deficiencies during an FDA inspection. Observations included inadequate investigations into product discrepancies and complaints, insufficient cleaning validation for non-dedicated equipment, and a lack of proper stability data to support drug product expiration dates. The firm also failed to ensure proper facility design to prevent contamination and maintain the building in a good state of repair.

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## Related Officers

- [FDA Investigator - Drugs Team at US Department of Health and Human Services](https://www.keypedia.com/people/rory-geyer/9f164dc5-df4d-4ecd-83d0-60fe6e73cf22)

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