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FDA Inspection
•Oceanitan, Inc.•April 6, 2023

Oceanitan, Inc. – FDA Inspection, Apr 6, 2023

Record Details

This FDA Inspection record concerns Oceanitan, Inc., with an inspection on April 6, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Oceanitan, Inc.
Inspection Date
April 6, 2023
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
Person
  • Alexandra B. Pitkin (FDA Associated Person)
View Company Profile

ID · aa10beee-9dcd-440f-8f35-b139035a11cd

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1202005
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards
Outcome
Form 483 issued
Enforcement
Warning Letter

FDA Citations

6
  1. 21 CFR 117.35(a)Sanitary operations - Plant maintenance
  2. 21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard
  3. 21 CFR 117.135(c)(1)Process preventive controls - Appropriate (Adequate)
  4. 21 CFR 117.130(a)(1)Hazard analysis - Identification of hazard
  5. 21 CFR 117.135(c)(1)Process preventive controls - Appropriate (Adequate)
  6. 21 CFR 117.35(a)Sanitary operations - Plant maintenance

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Oceanitan, Inc.

1
DateClassificationOfficeProject area
April 24, 2024VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
Other documents for Oceanitan, Inc.
  • FDA Inspection 1229114 - 2024-04-24

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