FDA Inspection 886449 — Pejivallera Tucurrique F&B S.A.
The FDA completed an inspection of Pejivallera Tucurrique F&B S.A. on July 8, 2014 in Paraiso. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 8, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Paraiso (Costa Rica)
Citations
| ID | CFR | Description |
|---|---|---|
| 1067 | 21 CFR 110.40(c) | Non food-contact equipment in processing area |
| 1329 | 21 CFR 113.100(a) | Process records - not done; not timely |
| 1331 | 21 CFR 113.100(a)(1) | Still retorts |
| 1483 | 21 CFR 113.87(a) | Operating processes not posted |
| 1484 | 21 CFR 113.87(a) | Vent not posted |
| 1485 | 21 CFR 113.87(a) | Scheduled processes not available |
| 1487 | 21 CFR 113.87(b) | Visual indicators not used |
| 1529 | 21 CFR 113.89 | Process deviation log/file |
| 1641 | 21 CFR 113.100(b) | Review not timely |
| 1648 | 21 CFR 113.40(a)(1) | No TID |
| 2167 | 21 CFR 113.40(b)(10) | No indicator |
| 2887 | 21 CFR 113.40(j) | Processing: conform to other systems |
| 3870 | 21 CFR 113.60(a)(2) | Glass containers; cold water vacuum check |
| 3876 | 21 CFR 113.60(c) | Coding - no mark, permanently visible |
| 4062 | 21 CFR 113.100(a) | Critical factors - no record |
| 4069 | 21 CFR 113.40(b)(14) | Heat distribution data, other retort installation |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |