FDA Inspection
Altrux Medical LLCAltrux Medical LLC – FDA Inspection, Dec 1, 2008
Record Details
This FDA Inspection record concerns Altrux Medical LLC, with an inspection on December 1, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Altrux Medical LLC
- Inspection Date
- December 1, 2008
- Product Type
- Biologics
View Company Profile
ID · cc7cc6ec-ba12-4874-8230-f31b7892ad92
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 555499
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.290(e)Documenting disposition of each HCT/P
- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.265(a)Acceptance criteria designed to prevent CD
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.160(b)(2)Procedures for complaints and other information
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Other FDA inspections of Altrux Medical LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Altrux Medical LLC
- FDA Inspection 701541 - 2010-12-13
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