FDA Inspection 1232950 — Intercos Europe S.p.A
The FDA completed an inspection of Intercos Europe S.p.A on March 15, 2024 in Agrate Brianza. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 15, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Agrate Brianza (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |