FDA Inspection 1017158 — Supercomal Medical Products, Sdn Bhd
The FDA completed an inspection of Supercomal Medical Products, Sdn Bhd on May 4, 2017 in Sungai Petani. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 4, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sungai Petani (Malaysia)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |