FDA Inspection
Carvi, LLCCarvi, LLC – FDA Inspection, Jan 27, 2014
Record Details
This FDA Inspection record concerns Carvi, LLC, with an inspection on January 27, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Carvi, LLC
- Inspection Date
- January 27, 2014
- Product Type
- Biologics
View Company Profile
ID · 38414793-973a-4bc9-982a-1924ad901990
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 865390
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.265(e)Documentation elements for activities
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Carvi, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 28, 2025 | Not classified | Dallas District Office | |
| August 8, 2017 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Carvi, LLC
- FDA Inspection 1261644 - 2025-01-28
- FDA Inspection 1020886 - 2017-08-08
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.