Company
United StatesStat Medical Devices, Inc., North Miami Beach, FL – FDA Inspections
Inspection records and compliance data for Stat Medical Devices, Inc. in North Miami Beach, Florida. 7 FDA inspections on record (3 OAI), 1 Form 483, 1 warning letter, last inspected March 18, 2025.
Company Profile
This profile covers Stat Medical Devices, Inc. based in North Miami Beach, Florida, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 3
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected December 5, 2008. Last inspected March 18, 2025.
Most cited issue areas
- Individual Report of Malfunction4 inspections
- Evaluation of suppliers, contractors, etc., requirements3 inspections
- Lack of or inadequate complaint procedures3 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 18, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1264028 |
| November 7, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1190227 |
| May 20, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 973076 |
| February 20, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 915029 |
| August 21, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 846140 |
| February 18, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 650310 |
| December 5, 2008 | OAI | Medical Devices & Rad Health · Compliance: Devices | 551179 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Stat Medical Devices, Inc.
FEI Number
1000525253
Address
2056 NE 153rd St, North Miami Beach, Florida 33162, United States
Country
United States
ID: 5d183644-10cd-4b19-bd80-8e8cd07c9d6e