Company
United StatesKutol Products Company, Inc., Sharonville, OH – FDA Inspections
Inspection records and compliance data for Kutol Products Company, Inc. in Sharonville, Ohio. 6 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 04, 2025.
Company Profile
This profile covers Kutol Products Company, Inc. based in Sharonville, Ohio, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 4
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 9, 2010. Last inspected March 4, 2025.
Most cited issue areas
- Absence of Written Procedures4 inspections
- Procedures not in writing, fully followed2 inspections
- Procedures to be written and followed2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 4, 2025 | OAI | Human Drugs · Drug Quality Assurance | 1256355 |
| March 3, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1119429 |
| September 29, 2015 | VAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 943842 |
| January 2, 2014 | VAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 861942 |
| October 11, 2012 | NAI | Foods & Cosmetics, Human Drugs · Colors and Cosmetics Technology | 801788 |
| April 9, 2010 | VAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 658346 |
FDA documents
Form 483s (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Kutol Products Company, Inc.
FEI Number
1513988
Address
100 Partnership Way, Sharonville, Ohio 45241, United States
Country
United States
ID: 0fa88356-5df6-440a-a60c-792dc11595a0