Stat Medical Devices, Inc.November 7, 2022

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Stat Medical Devices, Inc.

Record Details

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.

Company: Stat Medical Devices, Inc.
Inspection Date: November 7, 2022
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Ashley A. Mutawakkil

Open in Dashboard

ID · 8ffe2c74-2620-4a2e-adf8-41414a70bb28