Kutol Products Company
FDA inspection history in SHARONVILLE, Ohio, 2020 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at SHARONVILLE, Ohio.
- 2025One Form 483, at SHARONVILLE, Ohio.
- 2025The longest 483 on file: 7 observations over 21 pages at SHARONVILLE, Ohio.
Cited most
Across all Kutol Products observations on file
- 21 CFR 211.100(a)Written procedures; deviations3
- 21 CFR 211.67(a)Equipment cleaning and maintenance3
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.165(b)Testing and release for distribution1
- 21 CFR 211.192Production record review1
The complete Kutol Products file.
All 2 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
SHARONVILLE, Ohio
Two Form 483s · 2020 to 2025 · 14 observations
Latest: Form 483, Mar 4, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-04 | 483 Form 483 | SHARONVILLE, Ohio | 7 | $99 |
| 2020-03-03 | 483 Form 483 | SHARONVILLE, Ohio | 7 | $99 |
Investigators on these documents
FEI number 1513988 · most recent document Mar 4, 2025
About Kutol Products Company
How many FDA Form 483s has Kutol Products Company received?
FDA Intel has 2 Form 483s on file for Kutol Products Company; the most recent is dated Mar 4, 2025.
When was Kutol Products Company last inspected by FDA?
The most recent FDA inspection document on file for Kutol Products Company is a Form 483 dated Mar 4, 2025, for the site in SHARONVILLE, Ohio.
What did FDA cite at Kutol Products Company?
The regulations cited most in the observations on file for Kutol Products Company are 21 CFR 211.100(a) (Written procedures; deviations), 3 times; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 3 times; 21 CFR 211.160(b) (General requirements), 1 time.