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Form 483

Comfort Acrylics, Inc. Form 483, 2019-04-19

FDA issued a Form 483 to Comfort Acrylics, Inc. on 2019-04-19 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Comfort Acrylics, Inc. · Camas, United States · Issued April 19, 2019

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

19 Apr 2019
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Paul M Kawamoto

19 Apr 2019
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Paul M Kawamoto

Inspected site

CAComfort Acrylics, Inc.Camas, United States

Inspection team

PMPaul M Kawamoto

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.40Cited across public-safe Form 483 observations2x

Source document

PDF
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Form 483 source document

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Full 483 report

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The source PDF, 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