Criticare Systems (Malaysia) Sdn. Bhd. — FDA Facility Profile
Criticare Systems (Malaysia) Sdn. Bhd. is an FDA-inspected facility (FEI 3008727514) located in Nusajaya, MY. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Jun 23, 2015: No Action Indicated (NAI)
- Inspections on record
- 2 (1 OAI, 1 NAI)
- Last OAI inspection
- Sep 19, 2014
- Warning letters
- 1 listed by FDA for this FEI, latest Jan 15, 2015
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 23, 2015 | No Action Indicated (NAI) | No citations listed |
| Sep 19, 2014 | Official Action Indicated (OAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Lack of or inadequate procedures (21 CFR 820.100(a)) Documentation (21 CFR 820.100(b)) Training records (21 CFR 820.25(b)) and 2 more |
Facility details
- Company
- Criticare Systems (Malaysia) Sdn. Bhd.
- Location
- Nusajaya (MY)
- Source
- inspections