FDA Inspection
Vitalgo Inc.Vitalgo Inc. – FDA Inspection, May 28, 2015
Record Details
This FDA Inspection record concerns Vitalgo Inc., with an inspection on May 28, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vitalgo Inc.
- Inspection Date
- May 28, 2015
- Product Type
- Devices
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ID · f57c42e2-ebc5-4299-8517-469d66556c96
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 928196
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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Other FDA inspections of Vitalgo Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 6, 2026 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 13, 2024 | Not classified | Florida District Office | |
| October 27, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 17, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vitalgo Inc.
- FDA Inspection 1340152 - 2026-10-06
- FDA Inspection 1259206 - 2024-12-13
- FDA Inspection 1182276 - 2022-10-27
- FDA Inspection 1028775 - 2017-02-17
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