Oxygen Therapy Institute
FDA inspection history in Jacksonville, Florida, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Jacksonville, Florida.
Cited most
Across all Oxygen Therapy Institute observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 803.52If I am a manufacturer, what information must I submit in my individual adverse event reports?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.184Device history record1
- 21 CFR 820.198(a)Complaint files1
The complete Oxygen Therapy Institute file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Jacksonville, Florida
One Form 483 · 2023 · 12 observations
Latest: Form 483, Nov 17, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-11-17 | 483 Form 483 | Jacksonville, Florida | 12 | $99 |
Investigators on these documents
FEI number 1823393 · most recent document Nov 17, 2023
About Oxygen Therapy Institute
How many FDA Form 483s has Oxygen Therapy Institute received?
FDA Intel has 1 Form 483 on file for Oxygen Therapy Institute; the most recent is dated Nov 17, 2023.
When was Oxygen Therapy Institute last inspected by FDA?
The most recent FDA inspection document on file for Oxygen Therapy Institute is a Form 483 dated Nov 17, 2023, for the site in Jacksonville, Florida.
What did FDA cite at Oxygen Therapy Institute?
The regulations cited most in the observations on file for Oxygen Therapy Institute are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 803.52 (If I am a manufacturer, what information must I submit in my individual adverse event reports?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.