Plane It Safe, LLC
Form 483 issued October 30, 2019 · Winter Garden, Florida
- Inspection
- Oct 30, 2019
- Investigator
- Saundrea A. Munroe
- Observations
- 1
- Pages
- 2
- FEI number
- 3015172379
In short: On October 30, 2019, FDA issued a Form 483 with 1 observation to Plane It Safe, LLC in Winter Garden, Florida (FEI 3015172379) after an inspection that ran Oct 30, 2019. The investigator was Saundrea A. Munroe. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
This inspection in context
Saundrea A. Munroe
30 documents · 2018–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Florida.
The firmPlane It Safe, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Plane It Safe, LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Plane It Safe, LLC?
Saundrea A. Munroe is named on this Form 483, for the inspection of Oct 30, 2019. Each investigator has a profile showing what they cite most.
When was Plane It Safe, LLC inspected by FDA?
The inspection ran Oct 30, 2019, and the Form 483 is dated October 30, 2019.
How do I get the full Form 483 for Plane It Safe, 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.