Microlight Corporation of America
Form 483 issued July 11, 2018 · Sugar Land, Texas
- Inspection
- Jun 26 – Jul 11, 2018
- Investigator
- Jocelyn C. Turner
- Observations
- 1
- Pages
- 8
In short: On July 11, 2018, FDA issued a Form 483 with 1 observation to Microlight Corporation of America in Sugar Land, Texas after an inspection that ran Jun 26 – Jul 11, 2018. The investigator was Jocelyn C. Turner. Most observations concern records & documents; the most-cited regulation is 21 CFR 820.181 (device master record).
At a glance
1 of 1 observations on this 483 concern records & documents.
Most cited: 21 CFR 820.181 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A device master record…
This inspection in context
Jocelyn C. Turner
10 documents · 2015–2026
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmMicrolight Corporation of America history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.181
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Microlight Corporation of America?
FDA listed 1 observation on this Form 483, mostly about records & documents. The most-cited regulation is 21 CFR 820.181 (device master record). The opening words of each observation are shown on this page.
Who inspected Microlight Corporation of America?
Jocelyn C. Turner is named on this Form 483, for the inspection of Jun 26 – Jul 11, 2018. Each investigator has a profile showing what they cite most.
When was Microlight Corporation of America inspected by FDA?
The inspection ran Jun 26 – Jul 11, 2018, and the Form 483 is dated July 11, 2018.
How do I get the full Form 483 for Microlight Corporation of America?
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.