FDA Inspection 851681 — DCOOP. S.COOP. AND.
The FDA completed an inspection of DCOOP. S.COOP. AND. on September 19, 2013 in Monturque. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 19, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Monturque (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 1472 | 21 CFR 113.83 | Critical factors not stated |
| 1483 | 21 CFR 113.87(a) | Operating processes not posted |
| 1532 | 21 CFR 113.100(a)(7) | Other systems - records; critical factors |
| 1533 | 21 CFR 113.100(b) | Recording device records - dated; retort number |
| 1642 | 21 CFR 113.100(b) | Review not signed/dated |
| 2887 | 21 CFR 113.40(j) | Processing: conform to other systems |
| 4062 | 21 CFR 113.100(a) | Critical factors - no record |
| 4178 | 21 CFR 113.83 | Scheduled process - commercial production variation |