Company
MalaysiaGOLDREIGN PLASTICS (M) SDN BHD, Bandar Tasik Kesuma, Malaysia – FDA Inspections
Inspection records and compliance data for GOLDREIGN PLASTICS (M) SDN BHD in Bandar Tasik Kesuma. 2 FDA inspections on record, last inspected August 07, 2024.
Company Profile
This profile covers GOLDREIGN PLASTICS (M) SDN BHD based in Bandar Tasik Kesuma, Malaysia.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 8, 2019. Last inspected August 7, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of Written MDR Procedures1 inspection
- Nonconforming product control1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 7, 2024 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1246207 |
| August 8, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1108723 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
GOLDREIGN PLASTICS (M) SDN BHD
FEI Number
3008824562
Address
Lot 8, No 23 Jalan Kesuma 2/1, Bandar Tasik Kesuma, Malaysia
Country
Malaysia
ID: 4a0dff3c-df27-4391-a80e-75e7c88660d3