FDA Inspection
Bricon Technology GmbHBricon Technology GmbH – FDA Inspection, Feb 27, 2014
Record Details
This FDA Inspection record concerns Bricon Technology GmbH, with an inspection on February 27, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bricon Technology GmbH
- Inspection Date
- February 27, 2014
- Product Type
- Devices
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ID · e45f4923-80dc-481c-8ca7-ecf33c1a0447
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 867227
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bricon Technology GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 2, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bricon Technology GmbH
- FDA Inspection 1109312 - 2019-10-17
- FDA Inspection 1003949 - 2017-02-02
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