FDA Inspection
Bittium Biosignals Ltd.Bittium Biosignals Ltd. – FDA Inspection, Aug 29, 2013
Record Details
This FDA Inspection record concerns Bittium Biosignals Ltd., with an inspection on August 29, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bittium Biosignals Ltd.
- Inspection Date
- August 29, 2013
- Product Type
- Devices
View Company Profile
ID · f27225c8-0000-491c-a787-aef8e30a0c39
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 849649
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(e)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Bittium Biosignals Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bittium Biosignals Ltd.
- FDA Inspection 942011 - 2015-07-16
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