Company
United StatesGunnell Llc, Elk City, OK – FDA Inspections
Inspection records and compliance data for Gunnell Llc in Elk City, Oklahoma. 4 FDA inspections on record (1 OAI), last inspected February 18, 2016.
Company Profile
This profile covers Gunnell Llc based in Elk City, Oklahoma, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 30, 2010. Last inspected February 18, 2016.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Purchasing controls, Lack of or inadequate procedures2 inspections
- Report of risk to health2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 18, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 959099 |
| August 24, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 793234 |
| June 23, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 732620 |
| June 30, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 670779 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Gunnell Llc
FEI Number
3009255757
Address
321 W 12th St, Elk City, Oklahoma 73644, United States
Country
United States
ID: f118929d-72c5-4b43-bca7-ee1a4f559704