FDA Inspection
Geneoscopy, Inc.Geneoscopy, Inc. – FDA Inspection, May 17, 2023
Record Details
This FDA Inspection record concerns Geneoscopy, Inc., with an inspection on May 17, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a416b54d-d22f-4a2b-8b64-85d4419b7431
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1205472
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Geneoscopy, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 14, 2025 | Not classified | Kansas City District Office | Compliance: Medical Devices |
| April 27, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Geneoscopy, Inc.
- FDA Inspection 1269637 - 2025-05-14
- FDA Inspection 1208391 - 2023-04-27
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