FDA Inspection 851015 — Bio-Technology General (Israel), Ltd.
The FDA completed an inspection of Bio-Technology General (Israel), Ltd. on Aug 1, 2013 in Kiryat Malachi. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 1, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kiryat Malachi (Israel)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |