FDA Inspection 800604 — Bioteque Corporation I-Lan Factory II
The FDA completed an inspection of Bioteque Corporation I-Lan Factory II on Aug 23, 2012 in Su-Ao Cheng. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 23, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Su-Ao Cheng (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |