Atlas

Form 483

Comfort Acrylics, Inc. Form 483, 2011-03-18

FDA issued a Form 483 to Comfort Acrylics, Inc. on 2011-03-18 with 4 public-safe observations.

483· Form 483 issued4 observations

Comfort Acrylics, Inc. · Camas, United States · Issued March 18, 2011

Overview

  • 4 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.

18 Mar 2011
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Sherri N Rohlf

18 Mar 2011
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Sherri N Rohlf

18 Mar 2011
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Sherri N Rohlf

18 Mar 2011
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Sherri N Rohlf

Inspected site

CAComfort Acrylics, Inc.Camas, United States

Inspection team

SNSherri N Rohlf

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)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