FDA Inspection 1205189 — Zarotti S.p.A.
The FDA completed an inspection of Zarotti S.p.A. on May 15, 2023 in Castellabate. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 15, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Castellabate (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1045 | 21 CFR 113.10 | Supervisors |
| 1471 | 21 CFR 113.83 | Scheduled processes not established |
| 1529 | 21 CFR 113.89 | Process deviation log/file |
| 2153 | 21 CFR 113.40(b)(2)(iii) | Adjusted to agree with TID |
| 2160 | 21 CFR 113.40(b)(5) | Distributor, horizontal retort: length, perforations |
| 2206 | 21 CFR 113.40(b)(15) | Measured, recorded |
| 3782 | 21 CFR 113.40(b)(11) | Suction outlet screens |