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FDA Inspection
•Pacific Exchange Distributors, LLC•July 25, 2023

Pacific Exchange Distributors, LLC – FDA Inspection, Jul 25, 2023

Record Details

This FDA Inspection record concerns Pacific Exchange Distributors, LLC, with an inspection on July 25, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Pacific Exchange Distributors, LLC
Inspection Date
July 25, 2023
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
Person
  • Alexandra B. Pitkin (FDA Associated Person)
View Company Profile

ID · 1829f034-dad0-4ceb-8426-2a16b8ded179

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1210798
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards
Outcome
Form 483 issued

FDA Citations

16
  1. 21 CFR 114.83Scheduled process establishment
  2. 21 CFR 114.10Personnel
  3. 21 CFR 108.25(c)(1)Registration
  4. 21 CFR 123.8(a)(3)Verification - record review - frequency
  5. 21 CFR 123.7(c)Corrective action per regulation
  6. 21 CFR 123.6(c)(2)Monitoring - none
  7. 21 CFR 123.6(c)(5)Corrective action plan
  8. 21 CFR 123.6(c)(6)Verification procedures - adequacy
  9. 21 CFR 108.25(c)(1)Registration
  10. 21 CFR 114.10Personnel

Showing 10 of 16 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Pacific Exchange Distributors, LLC

7
DateClassificationOfficeProject area
October 16, 2018VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
March 7, 2017VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
December 11, 2014OAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
May 7, 2012VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
October 5, 2011OAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
View all 7 other inspections on the company page
Other documents for Pacific Exchange Distributors, LLC
  • FDA Inspection 1068962 - 2018-10-16
  • FDA Inspection 1005652 - 2017-03-07
  • FDA Inspection 907601 - 2014-12-11
  • FDA Inspection 782117 - 2012-05-07
  • FDA Inspection 749365 - 2011-10-05

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Contact
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Brooklyn, NY 11201
Scranton Office:
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201 Lackawanna Avenue
Scranton, PA, 18503
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