FDA Inspection 1206582 — OCEANA USA INC
The FDA completed an inspection of OCEANA USA INC on May 23, 2023 in Irwindale, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 23, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Irwindale, CA (United States)
Additional Details
FSVP
Citations
| ID | CFR | Description |
|---|---|---|
| 18254 | 21 CFR 1.502(a) | Develop FSVP |
| 18262 | 21 CFR 1.504(a) | Hazard analysis written |
| 18281 | 21 CFR 1.505(a)(2) | Evaluation - performance, risk |
| 18290 | 21 CFR 1.506(a)(1) | Approved supplier procedures - importer established |
| 18296 | 21 CFR 1.506(d)(1)(i) | Verification activity frequency |
| 18366 | 21 CFR 1.511(c)(1) | No CGMPs - supplier approval, performance, risk |
| 18388 | 21 CFR 1.511(c)(2)(i) | No CGMPs - approval procedures |
| 18549 | 21 CFR 1.511(c)(5)(i)(A)(4) | No CGMPs - record onsite audit |