FDA Inspection
Bio Gen Technologies, IncBio Gen Technologies, Inc – FDA Inspection, Apr 10, 2018
Record Details
This FDA Inspection record concerns Bio Gen Technologies, Inc, with an inspection on April 10, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f5231732-44d6-467c-8ac4-7fb6f982bf48
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048028
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bio Gen Technologies, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2024 | Not classified | New York District Office | Compliance: Devices |
| September 16, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bio Gen Technologies, Inc
- FDA Inspection 1247229 - 2024-08-16
- FDA Inspection 1152302 - 2021-09-16
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