FDA Inspection
Bio Gen Technologies, IncBio Gen Technologies, Inc – FDA Inspection, Aug 16, 2024
Record Details
This FDA Inspection record concerns Bio Gen Technologies, Inc, with an inspection on August 16, 2024, issued by the New York District Office, covering medical devices & rad health.
- Company
- Bio Gen Technologies, Inc
- Inspection Date
- August 16, 2024
- Product Type
- Medical Devices & Rad Health
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ID · 0014f035-37d1-4234-a9ab-7b576c6d27bf
Inspection Facts
- Inspection number
- 1247229
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bio Gen Technologies, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 10, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bio Gen Technologies, Inc
- FDA Inspection 1152302 - 2021-09-16
- FDA Inspection 1048028 - 2018-04-10
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