Stat Medical Devices, Inc
FDA inspection history across 2 sites, 2009 to 2022
- 2
- Warning letters
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
- Warning letter
2009: one warning letter; 2015: one warning letter; 2018: one close-out letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One warning letter, at Miami, Florida.
- 2015One warning letter, at Miami, Florida.
- 2018One close-out letter, at North Miami Beach, Florida.
- 2022One Form 483, at North Miami Beach, Florida.
Cited most
Across all Stat Medical Devices observations on file
- 21 CFR 820.25(b)Personnel1
- 21 CFR 820.50Purchasing controls1
The complete Stat Medical Devices file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
North Miami Beach, Florida
One Form 483 and one close-out letter · 2018 to 2022 · 2 observations
Latest: Form 483, Nov 7, 2022 →Miami, Florida
Two warning letters · 2009 to 2015
Latest: Warning letter, Jul 23, 2015 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-07 | 483 Form 483 | North Miami Beach, Florida | 2 | $99 |
| 2018-03-28 | Close-out Close-out letter | North Miami Beach, Florida | — | $99 |
| 2015-07-23 | Warning letter Warning letter | Miami, Florida | — | $99 |
| 2009-04-17 | Warning letter Warning letter | Miami, Florida | — | $99 |
Investigators on these documents
FEI number 1000525253 · most recent document Nov 7, 2022
About Stat Medical Devices, Inc
How many FDA Form 483s has Stat Medical Devices, Inc received?
FDA Intel has 1 Form 483 on file for Stat Medical Devices, Inc; the most recent is dated Nov 7, 2022.
When was Stat Medical Devices, Inc last inspected by FDA?
The most recent FDA inspection document on file for Stat Medical Devices, Inc is a Form 483 dated Nov 7, 2022, for the site in North Miami Beach, Florida.
What did FDA cite at Stat Medical Devices, Inc?
The regulations cited most in the observations on file for Stat Medical Devices, Inc are 21 CFR 820.25(b) (Personnel), 1 time; 21 CFR 820.50 (Purchasing controls), 1 time.
Has Stat Medical Devices, Inc received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Stat Medical Devices, Inc; the most recent is dated Jul 23, 2015.