FDA Inspection
Biorep Technologies, Inc.Biorep Technologies, Inc. – FDA Inspection, Dec 6, 2016
Record Details
This FDA Inspection record concerns Biorep Technologies, Inc., with an inspection on December 6, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f6045aef-b95e-4dac-b96b-50567854f87a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995537
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Biorep Technologies, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 5, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biorep Technologies, Inc.
- FDA Inspection 1239221 - 2024-04-26
- FDA Inspection 1043579 - 2018-02-05
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