FDA Inspection 847004 — APEX HEALTH CARE MFG., INC.
The FDA completed an inspection of APEX HEALTH CARE MFG., INC. on August 23, 2013 in Min Hsiung Shiang. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Min Hsiung Shiang (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 3270 | 21 CFR 820.80(c) | Documentation |