Atlas

Form 483

Shakti Group, USA, LLC Form 483, 2022-02-22

FDA issued a Form 483 to Shakti Group, USA, LLC on 2022-02-22 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Shakti Group, USA, LLC · Hamilton, United States · Issued February 22, 2022

Overview

  • 3 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

22 Feb 2022
21 CFR 117.165(b)

Allergen Controls Verif Procedures: Establish Implement

Cited by Kyle D Covill

22 Feb 2022
21 CFR 117.165(b)

Allergen Controls Verif Procedures: Establish Implement

Cited by Kyle D Covill

22 Feb 2022
21 CFR 117.165(b)

Allergen Controls Verif Procedures: Establish Implement

Cited by Kyle D Covill

Inspected site

SGShakti Group, USA, LLCHamilton, United States

Inspection team

KDKyle D Covill

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.165(b)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere