Form 483

MusclMasster, LLC Form 483, 2020-03-18

FDA issued a Form 483 to MusclMasster, LLC on 2020-03-18 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

MusclMasster, LLC · Wheat Ridge, United States · Issued March 18, 2020

Overview

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

18 Mar 2020
21 CFR 111.430(b)

Records - packaging, labeling operations

Cited by Sheila Alaghemand

18 Mar 2020
21 CFR 111.430(b)

Records - packaging, labeling operations

Cited by Sheila Alaghemand

18 Mar 2020
21 CFR 111.475(b)(1)

Written procedures - holding; distributing

Cited by Sheila Alaghemand

18 Mar 2020
21 CFR 111.475(b)(1)

Written procedures - holding; distributing

Cited by Sheila Alaghemand

18 Mar 2020
21 CFR 111.553

Written procedures - product complaint

Cited by Sheila Alaghemand

Inspected site

MLMusclMasster, LLCWheat Ridge, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.430(b)Cited across public-safe Form 483 observations2x
21 CFR 111.475(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 111.553Cited across public-safe Form 483 observations2x
21 CFR 111.65Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 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