Company
FinlandBittium Biosignals Ltd., Kuopio, Finland – FDA Inspections
Inspection records and compliance data for Bittium Biosignals Ltd. in Kuopio. 2 FDA inspections on record (1 OAI), last inspected July 16, 2015.
Company Profile
This profile covers Bittium Biosignals Ltd. based in Kuopio, Finland.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 29, 2013. Last inspected July 16, 2015.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Documentation1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 16, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 942011 |
| August 29, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 849649 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bittium Biosignals Ltd.
FEI Number
1000425315
Address
Pioneerin Katu 6, Kuopio, Finland
Country
Finland
ID: be9eb8d1-a6ce-457b-b3f0-78004a4315a4