Company
United StatesGelCool Systems, Inc, Franklin, TN – FDA Inspections
Inspection records and compliance data for GelCool Systems, Inc in Franklin, Tennessee. 1 FDA inspection on record, last inspected March 07, 2016.
Company Profile
This profile covers GelCool Systems, Inc based in Franklin, Tennessee, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected March 7, 2016.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 7, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 962346 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
GelCool Systems, Inc
FEI Number
3010877629
Address
1548 Old Hillsboro Road, Franklin, Tennessee 37069, United States
Country
United States
ID: bd930efb-91f4-4122-a0a5-1ffbb2ad3a64