FDA Inspection
Indiana Organ Procurement OrganizationIndiana Organ Procurement Organization – FDA Inspection, Feb 20, 2018
Record Details
This FDA Inspection record concerns Indiana Organ Procurement Organization, with an inspection on February 20, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · a866d9d8-85e3-4bf0-b706-da4f299a93ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041521
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.200(d)Inspected routinely
- 21 CFR 1271.270(a)Accurate, indelible, legible
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Other FDA inspections of Indiana Organ Procurement Organization
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 18, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 11, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 29, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 4, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Indiana Organ Procurement Organization
- FDA Inspection 1237985 - 2024-04-12
- FDA Inspection 1112945 - 2019-11-18
- FDA Inspection 954469 - 2015-12-11
- FDA Inspection 829625 - 2013-04-29
- FDA Inspection 659047 - 2010-05-04
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