Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-04.
At a glance
Inspections
10
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Feb 2025 – 4 Mar 2025 | Human Drugs | 483 | View 483 → |
| 20 Feb 2020 – 3 Mar 2020 | Human Drugs | 483 | View 483 → |
| 24 Sep 2015 – 29 Sep 2015 | Human Drugs | 483 | View 483 → |
| 11 Dec 2013 – 2 Jan 2014 | Human Drugs | 483 | View 483 → |
| 11 Oct 2012 | Not recorded | 483 | View 483 → |
| 9 Apr 2010 | Not recorded | 483 | View 483 → |
| 4 Sep 2008 | Not recorded | Clean | |
| 24 May 2006 | Not recorded | Clean | |
| 30 Jul 2003 | Not recorded | Clean | |
| 1 Aug 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Mar 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Martin M Kimani, Rafeeq A Habeeb
4 Mar 2025
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Martin M Kimani, Rafeeq A Habeeb
Investigators
FDA investigators tied to this site in the record.
Lindsey M Schwierjohann2 insp.
Martin M Kimani1 insp.
Rafeeq A Habeeb1 insp.
Jon P Antoniou1 insp.
Joshua P Wireman1 insp.
Tracey L Harris1 insp.
Nicholas L Paulin1 insp.
David P Moorhead1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kutol Products Company's 6 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat