Oxygen Therapy Institute
Form 483 issued November 17, 2023 · Jacksonville, Florida
- Inspection
- Nov 13 – Nov 17, 2023
- Investigator
- David M. Wilkinson
- Observations
- 12
- Pages
- 8
- FEI number
- 1823393
In short: On November 17, 2023, FDA issued a Form 483 with 12 observations to Oxygen Therapy Institute in Jacksonville, Florida (FEI 1823393) after an inspection that ran Nov 13 – Nov 17, 2023. The investigator was David M. Wilkinson. Most observations concern cAPA and production & process controls.
At a glance
Observations span 4 systems, led by capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for acceptance activities have…
- 02
Procediues to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 03
Process control procedures that describe any process controls necessary to ensure conformance to specifications…
- 04
Procedures for quality audits…
This inspection in context
David M. Wilkinson
7 documents · 2018–2025
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Florida.
The firmOxygen Therapy Institute history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.80(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oxygen Therapy Institute?
FDA listed 12 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The opening words of each observation are shown on this page.
Who inspected Oxygen Therapy Institute?
David M. Wilkinson is named on this Form 483, for the inspection of Nov 13 – Nov 17, 2023. Each investigator has a profile showing what they cite most.
When was Oxygen Therapy Institute inspected by FDA?
The inspection ran Nov 13 – Nov 17, 2023, and the Form 483 is dated November 17, 2023.
How do I get the full Form 483 for Oxygen Therapy Institute?
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.