FDA Inspection 671128 — Lodato Gennaro & C S.p.A.
The FDA completed an inspection of Lodato Gennaro & C S.p.A. on July 6, 2010 in Castel San Giorgio. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 6, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Castel San Giorgio (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1471 | 21 CFR 113.83 | Scheduled processes not established |
| 1473 | 21 CFR 113.83 | Scheduled process - scientific methods not used |
| 1501 | 21 CFR 113.89 | Evaluation records |
| 1529 | 21 CFR 113.89 | Process deviation log/file |
| 1599 | 21 CFR 110.37(b)(5) | Backflow prevention |
| 1641 | 21 CFR 113.100(b) | Review not timely |
| 3862 | 21 CFR 113.60(a)(1) | Teardown examinations - did not perform |
| 3863 | 21 CFR 113.60(a)(1) | Teardown examinations - frequency (S) |
| 3864 | 21 CFR 113.60(a)(1) | Recording of teardown examinations |
| 4524 | 21 CFR 108.35(g) | Approved school |