Innovative Sterilization Technologies
FDA inspection history in Dayton, Ohio, 2015 to 2022
- 2
- Close-outs
- 2
- Form 483s
Every document, by year
- Close-out
- Form 483
2015: one Form 483; 2019: one close-out letter; 2022: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Dayton, Ohio.
- 2015The longest 483 on file: 4 observations over 4 pages at Dayton, Ohio.
- 2019One close-out letter, at Dayton, Ohio.
- 2022One close-out letter and one Form 483, at Dayton, Ohio.
Cited most
Across all Innovative Sterilization Technologies observations on file
- 21 CFR 820.30(a)Design controls4
- 21 CFR 820.40Document controls1
- 21 CFR 820.70(b)Production and process controls1
The complete Innovative Sterilization Technologies file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Dayton, Ohio
Two close-out letters and two Form 483s · 2015 to 2022 · 6 observations
Latest: Close-out, Dec 27, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-27 | Close-out Close-out letter | Dayton, Ohio | — | $99 |
| 2022-01-13 | 483 Form 483 | Dayton, Ohio | 2 | $99 |
| 2019-03-20 | Close-out Close-out letter | Dayton, Ohio | — | $99 |
| 2015-11-04 | 483 Form 483 | Dayton, Ohio | 4 | $99 |
Investigators on these documents
FEI number 3010772758 · most recent document Dec 27, 2022
About Innovative Sterilization Technologies
How many FDA Form 483s has Innovative Sterilization Technologies received?
FDA Intel has 2 Form 483s on file for Innovative Sterilization Technologies; the most recent is dated Jan 13, 2022.
When was Innovative Sterilization Technologies last inspected by FDA?
The most recent FDA inspection document on file for Innovative Sterilization Technologies is a Form 483 dated Jan 13, 2022, for the site in Dayton, Ohio.
What did FDA cite at Innovative Sterilization Technologies?
The regulations cited most in the observations on file for Innovative Sterilization Technologies are 21 CFR 820.30(a) (Design controls), 4 times; 21 CFR 820.40 (Document controls), 1 time; 21 CFR 820.70(b) (Production and process controls), 1 time.