Microlight Corporation of America
Form 483 issued July 11, 2018 · Sugar Land, Texas
- Inspection
- Jun 26 – Jul 11, 2018
- Investigator
- Jocelyn C. Turner
- Observations
- 5
- Pages
- 8
- FEI number
- 3003654318
In short: On July 11, 2018, FDA issued a Form 483 with 5 observations to Microlight Corporation of America in Sugar Land, Texas (FEI 3003654318) after an inspection that ran Jun 26 – Jul 11, 2018. The investigator was Jocelyn C. Turner. Most observations concern records & documents and cAPA.
At a glance
Records & documents and capa account for 3 of 5 observations.
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…
- 02
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 03
Procedures or instructions for performing servicing activities and verifying that servicing meets specified requirements have…
- 04
EMPLOYEEfe) SIGNATURE Required records were not made readily available for review and…
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 5 observations on this Form 483, mostly about records & documents, cAPA and production & process controls. 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.