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FDA Inspection
•SANTIS PRODUCE LLC•February 16, 2023

FDA Inspection 1198132 - SANTIS PRODUCE LLC - February 16, 2023

Record Details

This FDA Inspection record concerns SANTIS PRODUCE LLC, with an inspection on February 16, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
SANTIS PRODUCE LLC
Inspection Date
February 16, 2023
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
Person
  • Mark A. Guerra (Issuing Officer)
View Company Profile

ID · 2bea3d0c-6e86-4d3e-95b7-3a0c0e203b5d

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1198132
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards
Outcome
Form 483 issued

FDA Citations

12
  1. 21 CFR 1.502(a)Develop FSVP
  2. 21 CFR 1.505(a)(2)Evaluation - performance, risk
  3. 21 CFR 1.506(d)(1)(i)Verification activity frequency
  4. 21 CFR 1.506(a)(1)Approved supplier procedures - importer established
  5. 21 CFR 1.504(a)Hazard analysis written
  6. 21 CFR 1.504(b)(1)Hazard analysis biological, chemical, physical
  7. 21 CFR 1.502(a)Develop FSVP
  8. 21 CFR 1.504(a)Hazard analysis written
  9. 21 CFR 1.504(b)(1)Hazard analysis biological, chemical, physical
  10. 21 CFR 1.505(a)(2)Evaluation - performance, risk

Showing 10 of 12 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of SANTIS PRODUCE LLC

3
DateClassificationOfficeProject area
April 7, 2026NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
April 25, 2024VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
May 11, 2021VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
Other documents for SANTIS PRODUCE LLC
  • FDA Inspection 1312232 - 2026-04-07
  • FDA Inspection 1236987 - 2024-04-25
  • FDA Inspection 1141752 - 2021-05-11

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