Company
MalaysiaInnolatex Sdn. Bhd., Port Klang, Malaysia – FDA Inspections
Inspection records and compliance data for Innolatex Sdn. Bhd. in Port Klang. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected July 27, 2023.
Company Profile
This profile covers Innolatex Sdn. Bhd. based in Port Klang, Malaysia.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected January 20, 2011. Last inspected July 27, 2023.
Most cited issue areas
- Lack of or inadequate process validation2 inspections
- Design control - no procedures1 inspection
- Design history file1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 27, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1215638 |
| March 9, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1009128 |
| November 3, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 752824 |
| January 20, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 709156 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Innolatex Sdn. Bhd.
FEI Number
3003117682
Address
Lot 591 & 594, Pandamaran Industrial Estate, Persiaran Raja Lumu, Port Klang, Malaysia
Country
Malaysia
ID: f67b8a34-aa42-434f-b1b6-c83e2fbe9c98