FDA Inspection 740692 — ORIZON S.A.
The FDA completed an inspection of ORIZON S.A. on Aug 12, 2011 in Coquimbo. 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). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 12, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Coquimbo (Chile)
Citations
| ID | CFR | Description |
|---|---|---|
| 1317 | 21 CFR 113.87(d) | Thermal processing - timing devices |
| 1529 | 21 CFR 113.89 | Process deviation log/file |
| 1734 | 21 CFR 113.40(a)(2)(iii) | Adjusted to agree with TID |
| 4529 | 21 CFR 108.35(c)(2)(ii) | Process change reporting to CFSAN |