Company
United StatesChitogen, Inc., Plymouth, MN – FDA Inspections
Inspection records and compliance data for Chitogen, Inc. in Plymouth, Minnesota. 5 FDA inspections on record, last inspected March 19, 2024.
Company Profile
This profile covers Chitogen, Inc. based in Plymouth, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected April 12, 2010. Last inspected March 19, 2024.
Most cited issue areas
- Lack of or inadequate final acceptance procedures3 inspections
- Lack of or inadequate process validation3 inspections
- Lack of or inadequate procedures2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 19, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1233462 |
| February 3, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 984816 |
| December 19, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 812627 |
| May 18, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 725056 |
| April 12, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 658411 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Chitogen, Inc.
FEI Number
3007788086
Address
12805 Highway 55 Ste 210, Plymouth, Minnesota 55441, United States
Country
United States
ID: 8ec01fb7-883f-47b5-aa45-b4d2c5b98b7d