FDA Inspection 670328 — Elleesse Di Nello Caporicci & C - .s.n.c.
The FDA completed an inspection of Elleesse Di Nello Caporicci & C - .s.n.c. on July 2, 2010 in Trevi. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 2, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Trevi (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1176 | 21 CFR 110.40(f) | Insufficient number of Q.C. instruments |
| 1303 | 21 CFR 113.81(f) | Critical Factors |
| 1330 | 21 CFR 113.100(a) | Process records - forms missing information |
| 1487 | 21 CFR 113.87(b) | Visual indicators not used |
| 1599 | 21 CFR 110.37(b)(5) | Backflow prevention |
| 1642 | 21 CFR 113.100(b) | Review not signed/dated |
| 1696 | 21 CFR 110.80(b)(3) | Holding foods - refrigerate/freeze/heat |
| 2392 | 21 CFR 110.80(b)(1) | Maintenance of equip., utensils, and finished food packaging |
| 2393 | 21 CFR 110.80(b)(1) | Teardown equipment/thorough cleaning |
| 3823 | 21 CFR 113.40(b)(1)(ii) | TID record of accuracy |
| 3862 | 21 CFR 113.60(a)(1) | Teardown examinations - did not perform |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4515 | 21 CFR 108.35(c)(2) | Process filing |
| 4524 | 21 CFR 108.35(g) | Approved school |