Company
United StatesNational Pen Tennessee LLC, Shelbyville, TN – FDA Inspections
Inspection records and compliance data for National Pen Tennessee LLC in Shelbyville, Tennessee. 2 FDA inspections on record, last inspected March 06, 2019.
Company Profile
This profile covers National Pen Tennessee LLC based in Shelbyville, Tennessee, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 30, 2014. Last inspected March 6, 2019.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Cleaning/maintenance records not kept1 inspection
- Retention time for some OTC drugs1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 6, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1084429 |
| January 30, 2014 | VAI | Human Drugs · Drug Quality Assurance | 863936 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
National Pen Tennessee LLC
FEI Number
3002962270
Address
342 Shelbyville Mills Rd, Shelbyville, Tennessee 37160, United States
Country
United States
ID: 7588c968-d683-40b6-9eda-47c7db42164e