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Form 483

Herbalife International of America, Inc Form 483, 2019-07-03

FDA issued a Form 483 to Herbalife International of America, Inc on 2019-07-03 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Herbalife International of America, Inc · Winston Salem, United States · Issued July 3, 2019

Overview

  • 4 public-safe observations are available for this inspection.
  • 3 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.

3 Jul 2019
21 CFR 111.15(c)(1)

Cleaning compounds

Cited by Radona R Boutte

3 Jul 2019
21 CFR 111.25(c)

Procedures - equipment - cleaning, sanitizing

Cited by Radona R Boutte

3 Jul 2019
21 CFR 111.75(i)

Corrective action plan

Cited by Radona R Boutte

3 Jul 2019
21 CFR 111.75(i)

Corrective action plan

Cited by Radona R Boutte

Inspected site

HIHerbalife International of America, IncWinston Salem, United States

Inspection team

RRRadona R Boutte

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.75(i)Cited across public-safe Form 483 observations2x
21 CFR 111.15(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.25(c)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 4 observations

The source PDF and 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