Stat Medical Devices, Inc
Form 483 issued November 7, 2022 · North Miami Beach, Florida
- Inspection
- Nov 3 – Nov 7, 2022
- Investigator
- Ashley A. Mutawakkil
- Observations
- 2
- Pages
- 4
- FEI number
- 1000525253
In short: On November 7, 2022, FDA issued a Form 483 with 2 observations to Stat Medical Devices, Inc in North Miami Beach, Florida (FEI 1000525253) after an inspection that ran Nov 3 – Nov 7, 2022. The investigator was Ashley A. Mutawakkil. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
Production & process controls and management controls account for 2 of 2 observations.
Most cited: 21 CFR 820.50 (1×) · 820.25(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 02
Procedures for training and identifying training needs have…
This inspection in context
Ashley A. Mutawakkil
4 documents · 2015–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Kansas.
The firmStat Medical Devices, Inc history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stat Medical Devices, Inc?
FDA listed 2 observations on this Form 483, mostly about production & process controls and management controls. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Stat Medical Devices, Inc?
Ashley A. Mutawakkil is named on this Form 483, for the inspection of Nov 3 – Nov 7, 2022. Each investigator has a profile showing what they cite most.
When was Stat Medical Devices, Inc inspected by FDA?
The inspection ran Nov 3 – Nov 7, 2022, and the Form 483 is dated November 7, 2022.
How do I get the full Form 483 for Stat Medical Devices, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.