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Form 483

James W. Baker, MD Form 483, 2017-06-19

FDA issued a Form 483 to James W. Baker, MD on 2017-06-19 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

James W. Baker, MD · Portland, United States · Issued June 19, 2017

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

19 Jun 2017
21 CFR 312.60

FD-1572, protocol compliance

Cited by Sherri N Rohlf

19 Jun 2017
21 CFR 312.62(b)

Case history records- inadequate or inadequate

Cited by Sherri N Rohlf

19 Jun 2017
21 CFR 50.25(a)(6)

Compensation, medical treatment in event of injury

Cited by Sherri N Rohlf

19 Jun 2017
21 CFR 50.55(f)

Documentation of permission by parents or guardian

Cited by Sherri N Rohlf

Inspected site

JWJames W. Baker, MDPortland, United States

Inspection team

SNSherri N Rohlf

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.60Cited across public-safe Form 483 observations1x
21 CFR 312.62(b)Cited across public-safe Form 483 observations1x
21 CFR 50.25(a)(6)Cited across public-safe Form 483 observations1x
21 CFR 50.55(f)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 4 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