# FDA 483 - Safesource Direct Glove Plant - December 05, 2025

Source: https://www.keypedia.com/records/483/safesource-direct-glove-plant/1b776d49-16e1-418c-85c8-ad76b5872057

> FDA 483 for Safesource Direct Glove Plant on December 05, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Safesource Direct Glove Plant
- Inspection Date: 2025-12-05
- Product Type: device
- Office Name: New Orleans District Office
- Summary: The FDA inspected Safesource Direct Glove Plant in Broussard, LA, from December 1-5, 2025. The inspection identified a significant issue with the firm's complaint handling procedures. Specifically, the process for evaluating customer complaints for medical device reportability and the need for investigation was found to be inadequately established and implemented.

## Related Officers

- [Monica C. Burgos Garcia](https://www.keypedia.com/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.keypedia.com/companies/safesource-direct-glove-plant/e9b90f36-c7e4-448a-a0d5-248a663d65c1

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea