FDA Inspection
Center For Organ Recovery & EducationCenter For Organ Recovery & Education – FDA Inspection, Jun 16, 2017
Record Details
This FDA Inspection record concerns Center For Organ Recovery & Education, with an inspection on June 16, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · bd6750fa-f955-495b-8137-767f2cd5c2b8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014416
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.290(b)Establishing a system
Full citation text and observation details available on the Dashboard.
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 |
| 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 |
| May 12, 2011 | VAI | 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 938841 - 2015-08-26
- FDA Inspection 835575 - 2013-06-11
- FDA Inspection 722618 - 2011-05-12
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