FDA Inspection
OCEANA USA INCOCEANA USA INC – FDA Inspection, May 23, 2023
Record Details
This FDA Inspection record concerns OCEANA USA INC, with an inspection on May 23, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 7e1a922c-b0f9-47d3-ad61-4f560726f09b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1206582
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 1.506(d)(1)(i)Verification activity frequency
- 21 CFR 1.502(a)Develop FSVP
- 21 CFR 1.505(a)(2)Evaluation - performance, risk
- 21 CFR 1.511(c)(1)No CGMPs - supplier approval, performance, risk
- 21 CFR 1.506(a)(1)Approved supplier procedures - importer established
- 21 CFR 1.511(c)(2)(i)No CGMPs - approval procedures
- 21 CFR 1.504(a)Hazard analysis written
- 21 CFR 1.511(c)(5)(i)(A)(4)No CGMPs - record onsite audit
- 21 CFR 1.502(a)Develop FSVP
- 21 CFR 1.504(a)Hazard analysis written
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Other FDA inspections of OCEANA USA INC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2026 | VAI | Los Angeles District Office | Foodborne Biological Hazards |
| May 21, 2025 | VAI | Los Angeles District Office | Foodborne Biological Hazards |
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