1102859
Societa' Italiana Progetti Ricerche E Sviluppo SRL — FEI 3006427262
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 26, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Limena (Italy)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 4356 | 21 CFR 211.166(b) | Tentative expiration date |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |