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Form 483

JW North America, Inc. Form 483, 2015-09-21

FDA issued a Form 483 to JW North America, Inc. on 2015-09-21 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

JW North America, Inc. · Rockland, United States · Issued September 21, 2015

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.

21 Sep 2015
21 CFR 820.20(e)

Quality System Procedures

Cited by David J Feria

21 Sep 2015
21 CFR 820.20(e)

Quality System Procedures

Cited by David J Feria

Inspected site

JNJW North America, Inc.Rockland, United States

Inspection team

DJDavid J Feria

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.20(e)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 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