# FDA 483 - Pure Source LLC - August 31, 2023

Source: https://www.keypedia.com/records/483/pure-source-llc/1c92409c-ba20-41f0-aa12-bfb020d10147

> FDA 483 for Pure Source LLC on August 31, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pure Source LLC
- Inspection Date: 2023-08-31
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Pure Source LLC, a contract manufacturer in Doral, FL, was inspected by the FDA, revealing significant deficiencies in its quality system. The firm failed to document the evaluation of potential suppliers, contractors, and consultants, and did not establish required quality agreements for medical devices. These issues indicate a failure to establish and maintain adequate purchasing controls as mandated by federal regulations.

## Related Documents

- [WARNING_LETTER - 2018-03-01](https://www.keypedia.com/records/warning_letter/pure-source-llc/405c1dc9-e565-4229-b8ba-1bd22fff1321)
- [483 - 2019-08-14](https://www.keypedia.com/records/483/pure-source-llc/efbbfd13-7a5b-4a38-9ed4-3df3ce6db000)
- [483 - 2025-10-21](https://www.keypedia.com/records/483/pure-source-llc/76754a27-6525-412f-93b0-476822be87ed)

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/pure-source-llc/442e7b43-8076-466c-8e41-0c5624502b15

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6