FDA Inspection 1014696 — ABA Medical Technology Co Ltd
The FDA completed an inspection of ABA Medical Technology Co Ltd on May 25, 2017 in Dongguan. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 25, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dongguan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |