FDA Inspection 1066253 — Acqualagna Tartufi, SRL
The FDA completed an inspection of Acqualagna Tartufi, SRL on September 8, 2018 in Acqualagna. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Acqualagna (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1045 | 21 CFR 113.10 | Supervisors |
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 1330 | 21 CFR 113.100(a) | Process records - forms missing information |
| 1483 | 21 CFR 113.87(a) | Operating processes not posted |
| 1500 | 21 CFR 113.89 | Evaluation by process authority |
| 16286 | 21 CFR 113.87(c) | Temperature-indicating device accuracy - initial temperature |
| 16288 | 21 CFR 113.100(b) | Review of processing and production records |
| 1640 | 21 CFR 113.100(b) | Record form not signed |
| 2888 | 21 CFR 113.40(j) | Critical factors - frequency measured, recorded |
| 2901 | 21 CFR 113.40(i) | Critical factor - scheduled process |
| 3859 | 21 CFR 113.60(a) | Frequency: visual closure examinations, record |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |