Company
MalaysiaKarex Industries Sdn Bhd, Pontian, Malaysia – FDA Inspections
Inspection records and compliance data for Karex Industries Sdn Bhd in Pontian. 2 FDA inspections on record, 1 Form 483, last inspected October 18, 2018.
Company Profile
This profile covers Karex Industries Sdn Bhd based in Pontian, Malaysia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 19, 2012. Last inspected October 18, 2018.
Most cited issue areas
- Documentation1 inspection
- Lack of or inadequate procedures for handling1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 18, 2018 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1074703 |
| April 19, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 782301 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Karex Industries Sdn Bhd
FEI Number
1000535235
Address
Ptd 7906 & 7907, Taman Pontian Jaya, Batu 34, Pontian, Malaysia
Country
Malaysia
ID: 8c4ba8e7-1195-4e46-a9f6-d1be8bbed4d3