# FDA 483 - Pure Source LLC - August 14, 2019

Source: https://www.keypedia.com/records/483/pure-source-llc/efbbfd13-7a5b-4a38-9ed4-3df3ce6db000

> FDA 483 for Pure Source LLC on August 14, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pure Source LLC
- Inspection Date: 2019-08-14
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Pure Source LLC, a contract OTC drug manufacturer in Doral, FL, revealed significant deficiencies in its quality system, production controls, and material management. The firm failed to thoroughly investigate discrepancies, properly manage deviations, and adequately qualify component suppliers, with some issues being repeat observations from previous inspections. These findings indicate a concerning lack of adherence to good manufacturing practices.

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## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

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