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 or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 10, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |