# FDA 483 - PN Medical, Inc. - October 17, 2019

Source: https://www.globalkeysolutions.net/records/483/pn-medical-inc/8a468106-7468-4a4f-b73f-15c765c0b398

> FDA 483 for PN Medical, Inc. on October 17, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PN Medical, Inc.
- Inspection Date: 2019-10-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: FX Medical, Inc., a medical device specification developer located in Cocoa Beach, FL, was cited by the FDA for inadequate procedures related to purchasing controls. The inspection revealed deficiencies in the firm's supplier evaluation reports and a failure to conduct required on-site audits of contract manufacturers. These issues indicate a lack of established processes to ensure that purchased products and services meet specified quality requirements.

## Related Officers

- [Principal ](https://www.globalkeysolutions.net/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.globalkeysolutions.net/companies/pn-medical-inc/f44fc6a5-f81a-4359-aea4-c978d8ae343e

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