# FDA 483 - Pathen Medical LLC - November 01, 2019

Source: https://www.globalkeysolutions.net/records/483/pathen-medical-llc/adbf6673-59b4-4920-aa11-256b49c27049

> FDA 483 for Pathen Medical LLC on November 01, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pathen Medical LLC
- Inspection Date: 2019-11-01
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Pathen Medical LLC, a medical device manufacturer in Sanford, FL, was inspected by the FDA. The inspection revealed deficiencies in the firm's purchasing controls, specifically regarding the evaluation and selection of third-party sterilization companies. Additionally, the validation effort for their (b)(4) Administration Sets lacked an appropriately designed Physical Performance Qualification.

## Related Officers

- [Joshua J. Silvestri](https://www.globalkeysolutions.net/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.globalkeysolutions.net/companies/pathen-medical-llc/479f69d6-b9b0-4865-8a62-6c9f1d4bed79

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