FDA Inspection
Gener8Gener8 – FDA Inspection, May 5, 2023
Record Details
This FDA Inspection record concerns Gener8, with an inspection on May 5, 2023, issued by the San Francisco District Office.
- Company
- Gener8
- Inspection Date
- May 5, 2023
- Person
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ID · 5aea0dad-de0e-427f-9d37-468e9628d82a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1206007
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gener8
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gener8
- FDA Inspection 1276873 - 2025-07-29
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