FDA Inspection 984897 — Anest Iwata Sparmax Co., Ltd.
The FDA completed an inspection of Anest Iwata Sparmax Co., Ltd. on July 14, 2016 in Changhua County. 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
- July 14, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Changhua County (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |