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FDA Inspection
•SHAKTI GROUP USA LLC•September 8, 2025

SHAKTI GROUP USA LLC – FDA Inspection, Sep 8, 2025

Record Details

This FDA Inspection record concerns SHAKTI GROUP USA LLC, with an inspection on September 8, 2025, issued by the New Jersey District Office, covering foods & cosmetics.

Company
SHAKTI GROUP USA LLC
Inspection Date
September 8, 2025
Product Type
Foods & Cosmetics
Office
New Jersey District Office
Person
  • Jesse N. Nardone (Issuing Officer)
View Company Profile

ID · 014444a3-832a-4193-bfd3-679403d083fb

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1263502
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards
Outcome
Form 483 issued

FDA Citations

10
  1. 21 CFR 1.506(e)(1)Verification activity before import, periodically
  2. 21 CFR 1.502(a)Develop FSVP
  3. 21 CFR 1.505(b)Supplier approval - document
  4. 21 CFR 1.505(a)(2)Evaluation - performance, risk
  5. 21 CFR 1.508(a)Corrective actions - take, document
  6. 21 CFR 1.504(d)Document review entity"s hazard analysis
  7. 21 CFR 1.506(b)Supplier verification - establish written procedures
  8. 21 CFR 1.506(a)(1)Approved supplier procedures - importer established
  9. 21 CFR 1.508(b)Investigate
  10. 21 CFR 1.504(d)Document review entity's hazard analysis

Full citation text and observation details available on the Dashboard.

Other FDA inspections of SHAKTI GROUP USA LLC

8
DateClassificationOfficeProject area
March 26, 2025NAINew Jersey District OfficeFood Composition, Standards, Labeling, and Economics
January 10, 2025VAINew Jersey District OfficeFoodborne Biological Hazards
August 12, 2022NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
February 22, 2022VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
March 8, 2021VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
View all 8 other inspections on the company page
Other documents for SHAKTI GROUP USA LLC
  • FDA Inspection 1263170 - 2025-03-26
  • FDA Inspection 1258156 - 2025-01-10
  • FDA Inspection 1177982 - 2022-08-12
  • FDA Inspection 1163031 - 2022-02-22
  • FDA Inspection 1137267 - 2021-03-08

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Contact
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370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
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201 Lackawanna Avenue
Scranton, PA, 18503
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