FDA Inspection 1246207 — GOLDREIGN PLASTICS (M) SDN BHD
The FDA completed an inspection of GOLDREIGN PLASTICS (M) SDN BHD on August 7, 2024 in Bandar Tasik Kesuma. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 7, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bandar Tasik Kesuma (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |