Company
United StatesCook Biotech, Inc., W Lafayette, IN – FDA Inspections
Inspection records and compliance data for Cook Biotech, Inc. in W Lafayette, Indiana. 4 FDA inspections on record, 1 Form 483, last inspected July 01, 2019.
Company Profile
This profile covers Cook Biotech, Inc. based in W Lafayette, Indiana, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 5, 2010. Last inspected July 1, 2019.
Most cited issue areas
- Deviations--evaluation, cause, corrective action1 inspection
- Records maintained concurrently1 inspection
- Report of Death or Serious Injury1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 1, 2019 | VAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1094943 |
| September 25, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 955632 |
| July 16, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 840289 |
| October 5, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 695491 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cook Biotech, Inc.
FEI Number
3002340648
Address
1425 Innovation Pl, W Lafayette, Indiana 47906, United States
Country
United States
ID: 762feaad-3ba4-431a-9503-d031707ac440