Company
BelgiumCardionics SA, Sint-Jans-Molenbeek, Belgium – FDA Inspections
Inspection records and compliance data for Cardionics SA in Sint-Jans-Molenbeek. 1 FDA inspection on record (1 OAI), 1 warning letter, last inspected July 29, 2015.
Company Profile
This profile covers Cardionics SA based in Sint-Jans-Molenbeek, Belgium.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
Inspected July 29, 2015.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- DHR - not or inadequately maintained1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 29, 2015 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 938680 |
FDA documents
Warning Letters (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cardionics SA
FEI Number
3003675391
Address
B-1080, Gabrielle Petitstraat 4/2, Sint-Jans-Molenbeek, Belgium
Country
Belgium
ID: 4bff49b2-75c2-4417-a9ff-8394f8a1daee