FDA Inspection
TEI Biosciences, Inc.TEI Biosciences, Inc. – FDA Inspection, Nov 2, 2018
Record Details
This FDA Inspection record concerns TEI Biosciences, Inc., with an inspection on November 2, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9c8b98cc-45ee-4ed3-816b-dce80708d30d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1070677
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of TEI Biosciences, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 12, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 1, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 15, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 15, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for TEI Biosciences, Inc.
- FDA Inspection 1205514 - 2023-05-17
- FDA Inspection 1156584 - 2021-11-12
- FDA Inspection 930231 - 2015-06-01
- FDA Inspection 770158 - 2012-02-15
- FDA Inspection 565051 - 2009-01-15
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