FDA Inspection
Steiner Biotechnology LLCSteiner Biotechnology LLC – FDA Inspection, Dec 16, 2016
Record Details
This FDA Inspection record concerns Steiner Biotechnology LLC, with an inspection on December 16, 2016, issued by the San Francisco District Office, covering medical devices & rad health.
- Company
- Steiner Biotechnology LLC
- Inspection Date
- December 16, 2016
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 2e181e3d-cb3d-4c14-b443-dd716c637e09
Inspection Facts
- Inspection number
- 997618
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
- 21 CFR 812.42Sponsor began study before IRB/FDA approval
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Other FDA inspections of Steiner Biotechnology LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2025 | Not classified | San Francisco District Office | Compliance: Medical Devices |
| January 16, 2025 | VAI | San Francisco District Office | Product Evaluation: Medical Devices |
| February 1, 2024 | Not classified | San Francisco District Office | Compliance: Devices |
| November 8, 2022 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 19, 2022 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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