FDA Inspection
Eone LaboratoriesEone Laboratories – FDA Inspection, Apr 9, 2019
Record Details
This FDA Inspection record concerns Eone Laboratories, with an inspection on April 9, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 4b9f69d5-a511-4502-a44b-070101c20dbb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1086218
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.200(e)Documentation of use
- 21 CFR 1271.270(a)Records incomplete
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Other FDA inspections of Eone Laboratories
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2025 | Not classified | Office of Inspections and Investigations | |
| August 30, 2023 | 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 1216308 - 2023-08-30
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