FDA Inspection 1204931 — SSN MEDICAL PRODUCTS SDN BHD
The FDA completed an inspection of SSN MEDICAL PRODUCTS SDN BHD on May 10, 2023 in Hulu Langat. 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
- May 10, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hulu Langat (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |