FDA Inspection 601113 — Pacific Nutritional Foods LLC
The FDA completed an inspection of Pacific Nutritional Foods LLC on July 23, 2009 in Tualatin, OR. 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
- July 23, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Tualatin, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1334 | 21 CFR 113.100(a)(4) | Aseptic processing - records |
| 1471 | 21 CFR 113.83 | Scheduled processes not established |
| 1500 | 21 CFR 113.89 | Evaluation by process authority |
| 1529 | 21 CFR 113.89 | Process deviation log/file |
| 1641 | 21 CFR 113.100(b) | Review not timely |
| 1642 | 21 CFR 113.100(b) | Review not signed/dated |
| 4515 | 21 CFR 108.35(c)(2) | Process filing |
| 4520 | 21 CFR 108.35(c)(3)(ii) | Process information availability |
| 4522 | 21 CFR 108.35(e) | Notify FDA - contamination |