FDA Inspection
Eone LaboratoriesEone Laboratories – FDA Inspection, Aug 30, 2023
Record Details
This FDA Inspection record concerns Eone Laboratories, with an inspection on August 30, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · f05b516e-68fa-4d12-b8d5-a8f7178149e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1216308
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.270(a)Records incomplete
- 21 CFR 1271.270(a)Records incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Eone Laboratories
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2025 | Not classified | Office of Inspections and Investigations | |
| April 9, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Eone Laboratories
- FDA Inspection 1294048 - 2025-09-23
- FDA Inspection 1086218 - 2019-04-09
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