# Pure Source LLC – FDA 483, Jul 28, 2026

Source: https://www.keypedia.com/records/483/pure-source-llc/08b700e8-c431-42aa-8f20-b470c02387fb

> FDA 483 for Pure Source LLC on July 28, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pure Source LLC
- Inspection Date: 2026-07-28
- Product Type: drugs
- Office Name: Florida District Office
- Summary: An FDA inspection of Pure Source, LLC, a medical device contract manufacturer in Doral, FL, revealed significant deficiencies in their risk management record-keeping. The firm failed to adequately maintain records for hazard identification, product risk assessments, and the incorporation of post-market feedback, specifically concerning particulate matter in their manufactured devices. These issues indicate a serious lapse in their quality system regarding risk management processes.

## Related Documents

- [483 - 2025-10-21](https://www.keypedia.com/records/483/pure-source-llc/76754a27-6525-412f-93b0-476822be87ed) — date: October 21, 2025
- [483 - 2023-08-31](https://www.keypedia.com/records/483/pure-source-llc/1c92409c-ba20-41f0-aa12-bfb020d10147) — date: August 31, 2023
- [483 - 2019-08-14](https://www.keypedia.com/records/483/pure-source-llc/efbbfd13-7a5b-4a38-9ed4-3df3ce6db000) — date: August 14, 2019
- [WARNING_LETTER - 2018-03-01](https://www.keypedia.com/records/warning_letter/pure-source-llc/405c1dc9-e565-4229-b8ba-1bd22fff1321) — date: March 1, 2018

## Related Officers

- [Gisselle I. Sensebe](https://www.keypedia.com/people/gisselle-i-sensebe/fbf83976-9888-44c0-a381-1993a933df4a)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9