FDA Inspection
Legacy of HopeLegacy of Hope – FDA Inspection, Jul 22, 2011
Record Details
This FDA Inspection record concerns Legacy of Hope, with an inspection on July 22, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Legacy of Hope
- Inspection Date
- July 22, 2011
- Product Type
- Biologics
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ID · 2e95dab5-103d-4878-8d71-2ff9ca38e045
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 737149
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.160(b)(4)Training of personnel
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Legacy of Hope
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 13, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 25, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 9, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Legacy of Hope
- FDA Inspection 1165715 - 2022-03-22
- FDA Inspection 1058061 - 2018-06-13
- FDA Inspection 961072 - 2016-02-25
- FDA Inspection 782279 - 2012-05-09
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