Form 483

Excelsior Nutrition, Inc. dba 4Excelsior Form 483, 2019-05-03

FDA issued a Form 483 to Excelsior Nutrition, Inc. dba 4Excelsior on 2019-05-03 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Excelsior Nutrition, Inc. dba 4Excelsior · Anaheim, United States · Issued May 3, 2019

Overview

  • 3 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.

3 May 2019
21 CFR 111.120

Quality control operations - components, packaging, labels

Cited by Kevin Lee

3 May 2019
21 CFR 111.610(a)

Records - available; FDA

Cited by Kevin Lee

3 May 2019
21 CFR 111.610(a)

Records - available; FDA

Cited by Kevin Lee

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.610(a)Cited across public-safe Form 483 observations2x
21 CFR 111.120Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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