FDA Inspection
Bio-Rad Laboratories GmbHBio-Rad Laboratories GmbH – FDA Inspection, Jan 22, 2015
Record Details
This FDA Inspection record concerns Bio-Rad Laboratories GmbH, with an inspection on January 22, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bio-Rad Laboratories GmbH
- Inspection Date
- January 22, 2015
- Product Type
- Devices
View Company Profile
ID · e3383369-6466-490f-8505-8878fc9aff72
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 915466
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
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Other FDA inspections of Bio-Rad Laboratories GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bio-Rad Laboratories GmbH
- FDA Inspection 971978 - 2016-04-14
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