Form 483

Baugher Enterprises, Inc Form 483, 2016-10-27

FDA issued a Form 483 to Baugher Enterprises, Inc on 2016-10-27 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Baugher Enterprises, Inc · Westminster, United States · Issued October 27, 2016

Overview

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

27 Oct 2016
21 CFR 120.12(c)

Records - signed/dated

Cited by Austin B Appler, Charles E Idjagboro

27 Oct 2016
21 CFR 120.6(b)

Sanitation monitoring

Cited by Austin B Appler, Charles E Idjagboro

27 Oct 2016
21 CFR 120.8(a)

HACCP plan not implemented

Cited by Austin B Appler, Charles E Idjagboro

27 Oct 2016
21 CFR 120.8(b)(3)

HACCP plan - critical limits not listed or not adequate

Cited by Austin B Appler, Charles E Idjagboro

Inspected site

BEBaugher Enterprises, IncWestminster, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.12(c)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)Cited across public-safe Form 483 observations1x
21 CFR 120.8(a)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(3)Cited across public-safe Form 483 observations1x

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