FDA Inspection
National Pen Tennessee LLCNational Pen Tennessee LLC – FDA Inspection, Jan 30, 2014
Record Details
This FDA Inspection record concerns National Pen Tennessee LLC, with an inspection on January 30, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- National Pen Tennessee LLC
- Inspection Date
- January 30, 2014
- Product Type
- Drugs
View Company Profile
ID · 71189900-1be1-45e4-97a4-55e1d0ee6019
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 863936
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.170(b)(3)Retention time for some OTC drugs
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of National Pen Tennessee LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for National Pen Tennessee LLC
- FDA Inspection 1084429 - 2019-03-06
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.