FDA Inspection
Toaster Labs, Inc.Toaster Labs, Inc. – FDA Inspection, Apr 4, 2023
Record Details
This FDA Inspection record concerns Toaster Labs, Inc., with an inspection on April 4, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ba6f621a-6cdb-4590-8171-914e13c11599
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1201733
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Toaster Labs, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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