Microvapor Devices LLC
Form 483 issued February 1, 2003 · West Columbia, South Carolina
- Inspection
- Jul 15 – Jul 18, 2025
- Investigator
- Gamal A. Norton
- Observations
- 7
- Pages
- 5
- FEI number
- 3011528328
In short: On February 1, 2003, FDA issued a Form 483 with 7 observations to Microvapor Devices LLC in West Columbia, South Carolina (FEI 3011528328) after an inspection that ran Jul 15 – Jul 18, 2025. The investigator was Gamal A. Norton. Most observations concern production & process controls and design controls; the most-cited regulation is 21 CFR 820.120 (device labeling).
At a glance
Production & process controls and design controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
The design was not validated under actual…
- 02
Labeling was not sufficiently examined by a designated individual for accuracy including…
- 03
A device master record…
- 04
Equipment calibrations have not…
This inspection in context
Gamal A. Norton
16 documents · 2003–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmMicrovapor Devices LLC 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 Microvapor Devices LLC?
FDA listed 7 observations on this Form 483, mostly about production & process controls, design controls and records & documents. The most-cited regulation is 21 CFR 820.120 (device labeling). The opening words of each observation are shown on this page.
Who inspected Microvapor Devices LLC?
Gamal A. Norton is named on this Form 483, for the inspection of Jul 15 – Jul 18, 2025. Each investigator has a profile showing what they cite most.
When was Microvapor Devices LLC inspected by FDA?
The inspection ran Jul 15 – Jul 18, 2025, and the Form 483 is dated February 1, 2003.
How do I get the full Form 483 for Microvapor Devices LLC?
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.