# FDA 483 - Nexera Medical, Inc. - August 23, 2022

Source: https://www.globalkeysolutions.net/records/483/nexera-medical-inc/b3349cee-a874-44df-80d4-74fa103c8885

> FDA 483 for Nexera Medical, Inc. on August 23, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nexera Medical, Inc.
- Inspection Date: 2022-08-23
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Nexera Medical, Inc. in Fort Lauderdale, FL, a specification developer, received a Form FDA 483 with one repeat observation. The firm failed to adequately establish and follow procedures for quality audits, specifically not performing internal audits since 2019 despite distributing SpectraShield Antimicrobial Respirator Masks. This observation was also cited in a previous 2012 FDA inspection.

## Related Documents

- [WARNING_LETTER - 2012-07-31](https://www.globalkeysolutions.net/records/warning_letter/nexera-medical-inc/988c4a01-dbb4-4250-8130-692b7ee1d05d)

## Related Officers

- [Ashley A. Mutawakkil](https://www.globalkeysolutions.net/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

Company: https://www.globalkeysolutions.net/companies/nexera-medical-inc/a864996c-54f1-4405-88bb-67adaf1811da

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