FDA Inspection
Aurum Group LlcAurum Group Llc – FDA Inspection, Jan 31, 2014
Record Details
This FDA Inspection record concerns Aurum Group Llc, with an inspection on January 31, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Aurum Group Llc
- Inspection Date
- January 31, 2014
- Product Type
- Biologics
View Company Profile
ID · 408ad54c-3f65-473d-a6dc-dc2ec07386af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 865392
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.265(e)Documentation elements for activities
- 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 Aurum Group Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Aurum Group Llc
- FDA Inspection 988047 - 2016-08-19
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