Raumedic Inc
Form 483 issued March 13, 2026 · Mills River, North Carolina
- Inspection
- Mar 9 – Mar 13, 2026
- Investigator
- Alex J. Wild
- Observations
- 3
- Pages
- 4
- FEI number
- 3012232668
In short: On March 13, 2026, FDA issued a Form 483 with 3 observations to Raumedic Inc in Mills River, North Carolina (FEI 3012232668) after an inspection that ran Mar 9 – Mar 13, 2026. The investigator was Alex J. Wild. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
2 of 3 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75 (1×) · 820.80 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for validation of processes did not adeqi lately include approval of changes…
- 02
Production and service provision was not adequately planned, carried out, monitored, and controlled to ensure that…
- 03
Records of the verification of purchased product…
This inspection in context
Alex J. Wild
4 documents · 2023–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.
The firmRaumedic Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Raumedic Inc?
FDA listed 3 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Raumedic Inc?
Alex J. Wild is named on this Form 483, for the inspection of Mar 9 – Mar 13, 2026. Each investigator has a profile showing what they cite most.
When was Raumedic Inc inspected by FDA?
The inspection ran Mar 9 – Mar 13, 2026, and the Form 483 is dated March 13, 2026.
How do I get the full Form 483 for Raumedic 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.