FDA Inspection
Steiner Biotechnology LLCSteiner Biotechnology LLC – FDA Inspection, Jun 28, 2019
Record Details
This FDA Inspection record concerns Steiner Biotechnology LLC, with an inspection on June 28, 2019, issued by the San Francisco District Office, covering medical devices & rad health.
- Company
- Steiner Biotechnology LLC
- Inspection Date
- June 28, 2019
- Product Type
- Medical Devices & Rad Health
- Person
- Dustin P. Tran (Issuing Officer)
View Company Profile
ID · 4bdb7463-c633-4f4a-a4e3-a08dbf796502
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1095715
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 58.10Notifying contractor of GLP status
- 21 CFR 58.130(a)Conduct: in accordance with protocol
- 21 CFR 58.130(c)Conduct: identification of test specimens
- 21 CFR 58.190(b)Archives: orderly storage, expedient retrieval
- 21 CFR 58.29(a)Personnel: education, training, experience
- 21 CFR 58.29(b)Personnel: summary of training, job description
- 21 CFR 58.35(b)(1)QAU: maintain a master schedule
- 21 CFR 58.35(b)(3)QAU: inspect study at adequate intervals
- 21 CFR 58.35(c)QAU: SOPs and required records
- 21 CFR 58.43(c)Facility: areas for disease diagnosis, treatment, & control
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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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