FDA Inspection 1100975 — Advanced Accelerator Applications (Italy) Srl
The FDA completed an inspection of Advanced Accelerator Applications (Italy) Srl on Sep 3, 2019 in Colleretto Giacosa. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 3, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Colleretto Giacosa (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |