FDA Inspection 668963 — SOLKY Affumicati e Salati di Fois Fernando Antioco
The FDA completed an inspection of SOLKY Affumicati e Salati di Fois Fernando Antioco on June 22, 2010 in Sant'Antioco. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 22, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Sant'Antioco (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1045 | 21 CFR 113.10 | Supervisors |
| 1176 | 21 CFR 110.40(f) | Insufficient number of Q.C. instruments |
| 1471 | 21 CFR 113.83 | Scheduled processes not established |
| 1473 | 21 CFR 113.83 | Scheduled process - scientific methods not used |
| 1483 | 21 CFR 113.87(a) | Operating processes not posted |
| 1487 | 21 CFR 113.87(b) | Visual indicators not used |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 1735 | 21 CFR 113.40(a)(2)(iii) | Unauthorized adjustment |
| 3823 | 21 CFR 113.40(b)(1)(ii) | TID record of accuracy |
| 3857 | 21 CFR 113.60(a) | Record: visual closure examination, qualified person |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4179 | 21 CFR 113.83 | Records of process establishment |
| 4523 | 21 CFR 108.35(f) | Recall procedures |
| 6021 | 21 CFR 123.10 | HACCP training or qualification |
| 908 | 21 CFR 123.6(d) | Signed and dated |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |