FDA Inspection 661837 — Inaudi Clemente & C. s.r.l.
The FDA completed an inspection of Inaudi Clemente & C. s.r.l. on April 28, 2010 in Borgo San Dalmazzo. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 28, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Borgo San Dalmazzo (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1471 | 21 CFR 113.83 | Scheduled processes not established |
| 1473 | 21 CFR 113.83 | Scheduled process - scientific methods not used |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |
| 2142 | 21 CFR 113.40(b)(1) | No accurate TID |
| 2386 | 21 CFR 110.80(a)(1) | Storage |
| 3862 | 21 CFR 113.60(a)(1) | Teardown examinations - did not perform |
| 4179 | 21 CFR 113.83 | Records of process establishment |