Company
United StatesCook Incorporated, Spencer, IN – FDA Inspections
Inspection records and compliance data for Cook Incorporated in Spencer, Indiana. 3 FDA inspections on record, 1 Form 483, last inspected May 26, 2017.
Company Profile
This profile covers Cook Incorporated based in Spencer, Indiana, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 20, 2010. Last inspected May 26, 2017.
Most cited issue areas
- Acceptance records1 inspection
- Documentation of disposition, justification, signature1 inspection
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 26, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1011967 |
| July 30, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 845571 |
| January 20, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 640284 |
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
Cook Incorporated
FEI Number
1825146
Address
1100 W Morgan St, Spencer, Indiana 47460, United States
Country
United States
ID: 9c76be9e-aca3-4334-ad3b-02f251909085