FDA Inspection 1102859 — Societa' Italiana Progetti Ricerche E Sviluppo SRL
The FDA completed an inspection of Societa' Italiana Progetti Ricerche E Sviluppo SRL on Sep 26, 2019 in Limena. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 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 |