Tactical Medical Systems Thermal
Form 483 issued August 8, 2025 · Oviedo, Florida
- Inspection
- Aug 6 – Aug 8, 2025
- Investigator
- Brandon P. Thompson
- Observations
- 14
- Pages
- 11
- FEI number
- 3009141585
In short: On August 8, 2025, FDA issued a Form 483 with 14 observations to Tactical Medical Systems Thermal in Oviedo, Florida (FEI 3009141585) after an inspection that ran Aug 6 – Aug 8, 2025. The investigator was Brandon P. Thompson. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by capa.
What FDA observed
Preview: the opening words of each observation- 01
Risk analysis was not…
- 02
Procedures for design control…
- 03
Procedures for the acceptance of in-process product have…
- 04
Procedures have not been established to control product that does not…
This inspection in context
Brandon P. Thompson
3 documents · 2022–2025
Cites 820.20(b) (management responsibility) more than any other section. Most of their documents are for sites in Florida.
The firmTactical Medical Systems Thermal history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tactical Medical Systems Thermal?
FDA listed 14 observations on this Form 483, mostly about cAPA, management controls and design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Tactical Medical Systems Thermal?
Brandon P. Thompson is named on this Form 483, for the inspection of Aug 6 – Aug 8, 2025. Each investigator has a profile showing what they cite most.
When was Tactical Medical Systems Thermal inspected by FDA?
The inspection ran Aug 6 – Aug 8, 2025, and the Form 483 is dated August 8, 2025.
How do I get the full Form 483 for Tactical Medical Systems Thermal?
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.