FDA Inspection 851015 — Bio-Technology General (Israel), Ltd.
The FDA completed an inspection of Bio-Technology General (Israel), Ltd. on August 1, 2013 in Kiryat Malachi. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 1, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- 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 |