# FDA 483 - Stat Medical Devices, Inc. - November 07, 2022

Source: https://www.globalkeysolutions.net/records/483/stat-medical-devices-inc/8ffe2c74-2620-4a2e-adf8-41414a70bb28

> FDA 483 for Stat Medical Devices, Inc. on November 07, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stat Medical Devices, Inc.
- Inspection Date: 2022-11-07
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Stat Medical Devices, Inc. in North Miami Beach, FL, received a Form FDA 483 following an inspection from November 3-7, 2022. The inspection revealed significant deficiencies in the firm's purchasing control procedures, including inadequate supplier audit frequencies and issues with contract sterilizer qualification. Additionally, the firm failed to ensure adequate training for its Quality Manager regarding Quality System Regulations.

## Related Documents

- [WARNING_LETTER - 2015-02-20](https://www.globalkeysolutions.net/records/warning_letter/stat-medical-devices-inc/354c07f1-8146-4c63-b686-bdc05ff36055)
- [483 - 2025-03-18](https://www.globalkeysolutions.net/records/483/stat-medical-devices-inc/eccbcc50-33ba-4820-9fc9-e3f5cafd7b5e)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/stat-medical-devices-inc/5d183644-10cd-4b19-bd80-8e8cd07c9d6e

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