Company
United StatesCook Inc, Ellettsville, IN – FDA Inspections
Inspection records and compliance data for Cook Inc in Ellettsville, Indiana. 3 FDA inspections on record, last inspected March 31, 2016.
Company Profile
This profile covers Cook Inc based in Ellettsville, Indiana, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected October 5, 2010. Last inspected March 31, 2016.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Production and Process Change Procedures, lack of or Inad.1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 31, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 971807 |
| August 28, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 798710 |
| October 5, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 695113 |
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 Inc
FEI Number
1000393132
Address
6300 N Matthews Dr, Ellettsville, Indiana 47429, United States
Country
United States
ID: b201606e-34d2-497d-bd5e-92a5a0e14b68