FDA Inspection 760420 — Conservas Ortiz S.A.
The FDA completed an inspection of Conservas Ortiz S.A. on Dec 13, 2011 in Ondarroa. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 13, 2011
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Ondarroa (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1300 | 21 CFR 113.81(c) | Fill |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 1641 | 21 CFR 113.100(b) | Review not timely |
| 2886 | 21 CFR 113.40(i) | Thermal process crit factors-measurement adequate & accurate |
| 933 | 21 CFR 123.8(a)(2)(ii) | Calibration - adequacy |