Company
MalaysiaCriticare Systems (Malaysia) Sdn. Bhd., Nusajaya, Malaysia – FDA Inspections
Inspection records and compliance data for Criticare Systems (Malaysia) Sdn. Bhd. in Nusajaya. 2 FDA inspections on record (1 OAI), 1 warning letter, last inspected June 23, 2015.
Company Profile
This profile covers Criticare Systems (Malaysia) Sdn. Bhd. based in Nusajaya, Malaysia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected September 19, 2014. Last inspected June 23, 2015.
Most cited issue areas
- Documentation1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 23, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 934707 |
| September 19, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 899521 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Criticare Systems (Malaysia) Sdn. Bhd.
FEI Number
3008727514
Address
No. 19 Jalan Mega 1/8, Taman Perindustrian Nusa Cemerlang, Nusajaya, Malaysia
Country
Malaysia
ID: 78c2a78d-bb9d-45b9-94d9-1d043d155fbd