910496
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 16, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Rafael, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |