FDA Inspection
Center For Organ Recovery & EducationCenter For Organ Recovery & Education – FDA Inspection, Sep 11, 2009
Record Details
This FDA Inspection record concerns Center For Organ Recovery & Education, with an inspection on September 11, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 11, 2009
- Product Type
- Biologics
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ID · 64958645-20b9-4624-a634-c0f5da5e70a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 608848
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
9- 21 CFR 1271.160(a)Program is appropriate for the HCT/Ps
- 21 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
- 21 CFR 1271.290(c)Identification code
- 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 1271.250(a)Controlling the labeling of HCT/Ps
- 21 CFR 1271.230(a)Validation & approval--established procedures
- 21 CFR 1271.270(a)Records maintained concurrently
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Other FDA inspections of Center For Organ Recovery & Education
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 8, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 16, 2017 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 26, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 11, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Center For Organ Recovery & Education
- FDA Inspection 1314392 - 2026-04-17
- FDA Inspection 1208722 - 2023-06-08
- FDA Inspection 1014416 - 2017-06-16
- FDA Inspection 938841 - 2015-08-26
- FDA Inspection 835575 - 2013-06-11
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