Nexair, LLC
Form 483 issued January 12, 2024 · Okeechobee, Florida
- Inspection
- Jan 8 – Jan 12, 2024
- Investigator
- Steven A. Brettler
- Observations
- 1
- Pages
- 5
- FEI number
- 1036503
In short: On January 12, 2024, FDA issued a Form 483 with 1 observation to Nexair, LLC in Okeechobee, Florida (FEI 1036503) after an inspection that ran Jan 8 – Jan 12, 2024. The investigator was Steven A. Brettler. 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(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Steven A. Brettler
15 documents · 2021–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
The firmNexair, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nexair, 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 Nexair, LLC?
Steven A. Brettler is named on this Form 483, for the inspection of Jan 8 – Jan 12, 2024. Each investigator has a profile showing what they cite most.
When was Nexair, LLC inspected by FDA?
The inspection ran Jan 8 – Jan 12, 2024, and the Form 483 is dated January 12, 2024.
How do I get the full Form 483 for Nexair, 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.