FDA Inspection 1102390 — Fu Shun Hsing Technology Co. Ltd.
The FDA completed an inspection of Fu Shun Hsing Technology Co. Ltd. on August 29, 2019 in Yung Kang District, Tainan City. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 29, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Yung Kang District, Tainan City (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |