Form 483

Buchanan Manufacturing, Inc. Form 483, 2014-08-28

FDA issued a Form 483 to Buchanan Manufacturing, Inc. on 2014-08-28 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Buchanan Manufacturing, Inc. · Buchanan, United States · Issued August 28, 2014

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.

28 Aug 2014
21 CFR 120.7(c)

All hazards not considered

Cited by Thomas B Smith

28 Aug 2014
21 CFR 120.8(b)(1)

HACCP plan - food hazards not listed

Cited by Thomas B Smith

28 Aug 2014
21 CFR 120.11(b)

Validation - reviewer's qualifications

Cited by Thomas B Smith

28 Aug 2014
21 CFR 120.12(c)

Records - signed/dated

Cited by Thomas B Smith

28 Aug 2014
21 CFR 120.24(a)

Process controls - HACCP plan - 5 log reduction

Cited by Thomas B Smith

Inspected site

BMBuchanan Manufacturing, Inc.Buchanan, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.11(b)Cited across public-safe Form 483 observations1x
21 CFR 120.12(c)Cited across public-safe Form 483 observations1x
21 CFR 120.24(a)Cited across public-safe Form 483 observations1x
21 CFR 120.24(c)Cited across public-safe Form 483 observations1x
21 CFR 120.7(c)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(1)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