International Medical Development, Inc
Form 483 issued February 12, 2021 · Huntsville, Utah
- Inspection
- Feb 8 – Feb 12, 2021
- Investigator
- James R. Montero
- Observations
- 2
- Pages
- 10
- FEI number
- 1000220636
In short: On February 12, 2021, FDA issued a Form 483 with 2 observations to International Medical Development, Inc in Huntsville, Utah (FEI 1000220636) after an inspection that ran Feb 8 – Feb 12, 2021. The investigator was James R. Montero. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(i) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change have…
This inspection in context
James R. Montero
10 documents · 2014–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Utah.
The firmInternational Medical Development, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at International Medical Development, Inc?
FDA listed 2 observations on this Form 483, mostly about 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 International Medical Development, Inc?
James R. Montero is named on this Form 483, for the inspection of Feb 8 – Feb 12, 2021. Each investigator has a profile showing what they cite most.
When was International Medical Development, Inc inspected by FDA?
The inspection ran Feb 8 – Feb 12, 2021, and the Form 483 is dated February 12, 2021.
How do I get the full Form 483 for International Medical Development, 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.