RAC Medical Solutions
Form 483 issued August 7, 2025 · Bruceton, Tennessee
- Inspection
- Aug 4 – Aug 7, 2025
- Investigator
- Javelle P. Spann
- Observations
- 10
- Pages
- 8
- FEI number
- 3018783057
In short: On August 7, 2025, FDA issued a Form 483 with 10 observations to RAC Medical Solutions in Bruceton, Tennessee (FEI 3018783057) after an inspection that ran Aug 4 – Aug 7, 2025. The investigator was Javelle P. Spann. Most observations concern production & process controls and records & documents; the most-cited regulation is 21 CFR 820.184 (device history record).
At a glance
Production & process controls and records & documents account for 6 of 10 observations.
Most cited: 21 CFR 820.184 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for device history records…
- 02
Corrective and preventive action activities and/or results…
- 03
A device history record…
- 0421 CFR 801.20(a)21 CFR 830
The labels of the medical device(s) do not bear a tmique device identifier (UDI) that meet…
This inspection in context
Javelle P. Spann
2 documents · 2022–2025
Cites 820.184 (device history record) more than any other section. Most of their documents are for sites in Tennessee.
The firmRAC Medical Solutions history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.184
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RAC Medical Solutions?
FDA listed 10 observations on this Form 483, mostly about production & process controls, records & documents and cAPA. The most-cited regulation is 21 CFR 820.184 (device history record). The opening words of each observation are shown on this page.
Who inspected RAC Medical Solutions?
Javelle P. Spann is named on this Form 483, for the inspection of Aug 4 – Aug 7, 2025. Each investigator has a profile showing what they cite most.
When was RAC Medical Solutions inspected by FDA?
The inspection ran Aug 4 – Aug 7, 2025, and the Form 483 is dated August 7, 2025.
How do I get the full Form 483 for RAC Medical Solutions?
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.