FDA Inspection
Stat Medical Devices, Inc.Stat Medical Devices, Inc. – FDA Inspection, Dec 5, 2008
Record Details
This FDA Inspection record concerns Stat Medical Devices, Inc., with an inspection on December 5, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Stat Medical Devices, Inc.
- Inspection Date
- December 5, 2008
- Product Type
- Devices
View Company Profile
ID · de906a15-66cc-4226-b633-b0eea962f40d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 551179
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(f)Design verification procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.198(e)(6)Results of investigation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Stat Medical Devices, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2025 | VAI | Florida District Office | Compliance: Medical Devices |
| November 7, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 20, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 20, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 21, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Stat Medical Devices, Inc.
- FDA Inspection 1264028 - 2025-03-18
- FDA Inspection 1190227 - 2022-11-07
- FDA Inspection 973076 - 2016-05-20
- FDA Inspection 915029 - 2015-02-20
- FDA Inspection 846140 - 2013-08-21
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