FDA Inspection
Allograft Innovations, LLCAllograft Innovations, LLC – FDA Inspection, Oct 3, 2012
Record Details
This FDA Inspection record concerns Allograft Innovations, LLC, with an inspection on October 3, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Allograft Innovations, LLC
- Inspection Date
- October 3, 2012
- Product Type
- Biologics
View Company Profile
ID · 70b323e1-4b08-4d06-b848-6bbb482911d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 801430
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
12- 21 CFR 1271.160(b)(3)Actions verified, short and long term solutions
- 21 CFR 1271.160(b)(3)Problem description, disposition, date et. al.
- 21 CFR 1271.190(d)(2)Documentation of activities
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.265(c)(2)Improperly released for distribution
- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.225Verification/validation
- 21 CFR 1271.230(a)Validation & approval--established procedures
- 21 CFR 1271.270(a)Records incomplete
Showing 10 of 12 citations.
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Other FDA inspections of Allograft Innovations, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 6, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Allograft Innovations, LLC
- FDA Inspection 739353 - 2011-08-08
- FDA Inspection 579202 - 2009-05-06
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