Form 483

E. Excel USA, LLC Form 483, 2015-03-25

FDA issued a Form 483 to E. Excel USA, LLC on 2015-03-25 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

E. Excel USA, LLC · Sandy, United States · Issued March 25, 2015

Overview

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

Inspectional observations

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

25 Mar 2015
21 CFR 111.75(a)(1)(i)

Component - verify identity, dietary ingredient

Cited by Christine L Williams

25 Mar 2015
21 CFR 111.75(h)(2)

Tests, examinations - scientifically valid

Cited by Christine L Williams

25 Mar 2015
21 CFR 111.75(a)(1)(i)

Component - verify identity, dietary ingredient

Cited by Christine L Williams

25 Mar 2015
21 CFR 111.75(h)(2)

Tests, examinations - scientifically valid

Cited by Christine L Williams

Inspected site

EEE. Excel USA, LLCSandy, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations2x
21 CFR 111.75(h)(2)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

Every observation in full, 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