FDA Inspection
GOLDREIGN PLASTICS (M) SDN BHDGOLDREIGN PLASTICS (M) SDN BHD – FDA Inspection, Aug 7, 2024
Record Details
This FDA Inspection record concerns GOLDREIGN PLASTICS (M) SDN BHD, with an inspection on August 7, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 58c58554-b5b4-4c10-8f38-615d745f3ca6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1246207
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of GOLDREIGN PLASTICS (M) SDN BHD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for GOLDREIGN PLASTICS (M) SDN BHD
- FDA Inspection 1108723 - 2019-08-08
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