1097015
Dead Sea Periclase — FEI 3000121060
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 18, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rotem Plants (Israel)
Citations
| ID | CFR | Description |
|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |