Company
MalaysiaCIBA VISION Johor Sdn. Bhd., Gelang Patah, Malaysia – FDA Inspections
Inspection records and compliance data for CIBA VISION Johor Sdn. Bhd. in Gelang Patah. 3 FDA inspections on record, 1 Form 483, last inspected November 17, 2016.
Company Profile
This profile covers CIBA VISION Johor Sdn. Bhd. based in Gelang Patah, Malaysia.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected May 28, 2009. Last inspected November 17, 2016.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 17, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 994394 |
| July 24, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 843962 |
| May 28, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 590119 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
CIBA VISION Johor Sdn. Bhd.
FEI Number
3006466212
Address
No. 1 Jalan Dpb/5, Gelang Patah, Malaysia
Country
Malaysia
ID: baf0e623-5e95-4d86-b4dd-b58510e11816