Form 483

Baugher Enterprises, Inc Form 483, 2008-10-14

FDA issued a Form 483 to Baugher Enterprises, Inc on 2008-10-14 with 6 public-safe observations.

483· Form 483 issued6 observations

Baugher Enterprises, Inc · Westminster, United States · Issued October 14, 2008

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

14 Oct 2008
21 CFR 110.35(e)

Storage of cleaned portable equipment (S)

Cited by Edette J Newby

14 Oct 2008
21 CFR 120.6(c)

SSOP records

Cited by Edette J Newby

14 Oct 2008
21 CFR 120.12(a)

Records required - not maintained

Cited by Edette J Newby

14 Oct 2008
21 CFR 120.24(a)

Process controls - HACCP plan - 5 log reduction

Cited by Edette J Newby

14 Oct 2008
21 CFR 120.24(b)

Process controls - direct treatment - not exempt

Cited by Edette J Newby

Inspected site

BEBaugher Enterprises, IncWestminster, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(e)Cited across public-safe Form 483 observations1x
21 CFR 120.12(a)Cited across public-safe Form 483 observations1x
21 CFR 120.24(a)Cited across public-safe Form 483 observations1x
21 CFR 120.24(b)Cited across public-safe Form 483 observations1x
21 CFR 120.25Cited across public-safe Form 483 observations1x
21 CFR 120.6(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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