FDA Inspection 857127 — Pancrazio S.P.A.
The FDA completed an inspection of Pancrazio S.P.A. on Oct 31, 2013 in Cava De' Tirreni. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 31, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Cava De' Tirreni (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1473 | 21 CFR 113.83 | Scheduled process - scientific methods not used |
| 1641 | 21 CFR 113.100(b) | Review not timely |
| 4181 | 21 CFR 113.89 | Process deviation identification |
| 4515 | 21 CFR 108.35(c)(2) | Process filing |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |