FDA Inspection
OneLegacyOneLegacy – FDA Inspection, Dec 5, 2013
Record Details
This FDA Inspection record concerns OneLegacy, with an inspection on December 5, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- OneLegacy
- Inspection Date
- December 5, 2013
- Product Type
- Biologics
View Company Profile
ID · 3fc698da-8861-4e9e-84a1-d6e6eabd9044
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 857702
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.190(b)(1)Clean, sanitary, orderly manner
- 21 CFR 1271.190(d)(1)Description of methods, schedule
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OneLegacy
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 26, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 23, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 9, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for OneLegacy
- FDA Inspection 1243810 - 2024-07-01
- FDA Inspection 1102405 - 2019-07-26
- FDA Inspection 989544 - 2016-09-23
- FDA Inspection 752525 - 2011-11-09
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