Cardionics SA — FDA Facility Profile
Cardionics SA is an FDA-inspected facility (FEI 3003675391) located in Sint-Jans-Molenbeek, BE. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Jul 29, 2015: Official Action Indicated (OAI)
- Inspections on record
- 1 (1 OAI)
- Last OAI inspection
- Jul 29, 2015
- Warning letters
- 1 listed by FDA for this FEI, latest Oct 21, 2015
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jul 29, 2015 | Official Action Indicated (OAI) | DHR - not or inadequately maintained (21 CFR 820.184) Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design validation- Lack of or inadequate procedures (21 CFR 820.30(g)) Lack of or inadequate procedures (21 CFR 820.100(a)) and 2 more |
Facility details
- Company
- Cardionics SA
- Location
- Sint-Jans-Molenbeek (BE)
- Source
- inspections