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Form 483

Generic Medical Devices, Inc. Form 483, 2010-09-09

FDA issued a Form 483 to Generic Medical Devices, Inc. on 2010-09-09 with 6 public-safe observations.

483· Form 483 issued6 observations

Generic Medical Devices, Inc. · Gig Harbor, United States · Issued September 9, 2010

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.

9 Sep 2010
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Graham N Giesen

9 Sep 2010
21 CFR 820.20(b)

Lack of or inadequate organizational structure

Cited by Graham N Giesen

9 Sep 2010
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Graham N Giesen

9 Sep 2010
21 CFR 820.100(b)

Documentation

Cited by Graham N Giesen

9 Sep 2010
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Graham N Giesen

Inspected site

GMGeneric Medical Devices, Inc.Gig Harbor, United States

Inspection team

GNGraham N Giesen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(d)Cited across public-safe Form 483 observations1x
21 CFR 820.20(b)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 6 observations

The source PDF and 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