Company
United StatesEnamelite LLC, Clarksville, TN – FDA Inspections
Inspection records and compliance data for Enamelite LLC in Clarksville, Tennessee. 1 FDA inspection on record, last inspected November 01, 2013.
Company Profile
This profile covers Enamelite LLC based in Clarksville, Tennessee, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected November 1, 2013.
Most cited issue areas
- Design control - no procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 1, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 853715 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Enamelite LLC
FEI Number
3003934132
Address
1753b Alpine Dr, Clarksville, Tennessee 37040, United States
Country
United States
ID: d9c57b13-4e94-4c1b-b487-f7ef8081e8ea