Kutol Products Company
Form 483 issued March 4, 2025 · SHARONVILLE, Ohio
- Inspection
- Feb 25 – Mar 4, 2025
- Investigators
- Martin M. Kimani· Rafeeq Habeeb
- Observations
- 7
- Pages
- 21
- FEI number
- 1513988
In short: On March 4, 2025, FDA issued a Form 483 with 7 observations to Kutol Products Company in SHARONVILLE, Ohio (FEI 1513988) after an inspection that ran Feb 25 – Mar 4, 2025. The investigators were Martin M. Kimani and Rafeeq Habeeb. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested through…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Martin M. Kimani
4 documents · 2025–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Ohio.
The firmKutol Products Company history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kutol Products Company?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected Kutol Products Company?
Martin M. Kimani and Rafeeq Habeeb are named on this Form 483, for the inspection of Feb 25 – Mar 4, 2025. Each investigator has a profile showing what they cite most.
When was Kutol Products Company inspected by FDA?
The inspection ran Feb 25 – Mar 4, 2025, and the Form 483 is dated March 4, 2025.
How do I get the full Form 483 for Kutol Products Company?
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.