FDA Inspection
Allograft Innovations, LLCAllograft Innovations, LLC – FDA Inspection, May 6, 2009
Record Details
This FDA Inspection record concerns Allograft Innovations, LLC, with an inspection on May 6, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Allograft Innovations, LLC
- Inspection Date
- May 6, 2009
- Product Type
- Biologics
View Company Profile
ID · c2960bf1-5905-4bda-b7dc-2cb0e742e327
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 579202
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
10- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.320(b)Designated complaint file
- 21 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.150(c)(2)Responsibility for review before distribution
- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.225Verification/validation
- 21 CFR 1271.270(a)Records incomplete
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Other FDA inspections of Allograft Innovations, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 3, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 8, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Allograft Innovations, LLC
- FDA Inspection 801430 - 2012-10-03
- FDA Inspection 739353 - 2011-08-08
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