Atlas

Form 483

Biofournil of America, Inc. Form 483, 2010-04-05

FDA issued a Form 483 to Biofournil of America, Inc. on 2010-04-05 with 3 public-safe observations.

483· Form 483 issued3 observations

Biofournil of America, Inc. · Seattle, United States · Issued April 5, 2010

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

5 Apr 2010
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Bryce E Mansfield

5 Apr 2010
21 CFR 110.40(a)

Materials and workmanship

Cited by Bryce E Mansfield

5 Apr 2010
21 CFR 110.80(a)(1)

Storage

Cited by Bryce E Mansfield

Inspected site

BOBiofournil of America, Inc.Seattle, United States

Inspection team

BEBryce E Mansfield

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited 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