Atlas

Form 483

Bush Brothers & Company Form 483, 2017-07-14

FDA issued a Form 483 to Bush Brothers & Company on 2017-07-14 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Bush Brothers & Company · Dandridge, United States · Issued July 14, 2017

Overview

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

Inspectional observations

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

14 Jul 2017
21 CFR 108.35(d)

Notify FDA - spoilage

Cited by Thomas B Smith, Markeesa M Scales

14 Jul 2017
21 CFR 113.100(b)

Record form not signed

Cited by Thomas B Smith, Markeesa M Scales

Inspected site

BBBush Brothers & CompanyDandridge, United States

Inspection team

TBThomas B Smith
MMMarkeesa M Scales

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.35(d)Cited across public-safe Form 483 observations1x
21 CFR 113.100(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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