FDA Inspection
ArekaAreka – FDA Inspection, Jul 17, 2025
Record Details
This FDA Inspection record concerns Areka, with an inspection on July 17, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f2a6ab54-f5db-411c-a0d6-79b1dc1a3415
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1276102
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.140(a)(3)Investigator's subject records inadequate
- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
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Other FDA inspections of Areka
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Areka
- FDA Inspection 963714 - 2016-02-22
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