FDA Inspection 672189 — T & C Di Marchetti Ulderico & C Snc
The FDA completed an inspection of T & C Di Marchetti Ulderico & C Snc on July 8, 2010 in Acqualagna. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 8, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Acqualagna (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1006 | 21 CFR 110.10(b)(8) | Personal food/drink/tobacco |
| 1040 | 21 CFR 113.10 | Operators |
| 1126 | 21 CFR 110.40(a) | Precluding contaminants |
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 1329 | 21 CFR 113.100(a) | Process records - not done; not timely |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1562 | 21 CFR 110.35(d) | Failure to clean - general |
| 1642 | 21 CFR 113.100(b) | Review not signed/dated |
| 2143 | 21 CFR 113.40(b)(1)(iv) | MIG - range |
| 2149 | 21 CFR 113.40(b)(1)(v) | TID not reference instrument |
| 2151 | 21 CFR 113.40(b)(2)(i) | Range, chart graduations |
| 3857 | 21 CFR 113.60(a) | Record: visual closure examination, qualified person |
| 4181 | 21 CFR 113.89 | Process deviation identification |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |
| 4528 | 21 CFR 108.35(c)(2)(ii) | Process change recording |