# FDA 483 - Safecor Health, LLC - October 19, 2017

Source: https://www.keypedia.com/records/483/safecor-health-llc/3cd0a460-a2f1-413b-b3fa-259262732805

> FDA 483 for Safecor Health, LLC on October 19, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safecor Health, LLC
- Inspection Date: 2017-10-19
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Safecor Health, LLC, a drug manufacturer and repacker in Woburn, MA, received a Form 483 with seven observations during an inspection from October 4-19, 2017. The observations primarily highlight significant deficiencies in the firm's Quality Unit, including failures in change control, CAPA management, vendor qualification, process validation, environmental monitoring justification, annual product reviews, and complaint handling procedures. These issues indicate a systemic lack of adherence to established quality control processes, leading to product recalls and potential risks to product quality.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

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