Atlas

Form 483

James W. Baker, MD Form 483, 2016-05-26

FDA issued a Form 483 to James W. Baker, MD on 2016-05-26 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

James W. Baker, MD · Portland, United States · Issued May 26, 2016

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

26 May 2016
21 CFR 312.60

FD-1572, protocol compliance

Cited by Sherri N Rohlf, Julian C Hanson, Carla V Jordan

26 May 2016
21 CFR 312.62(b)

Case history records- inadequate or inadequate

Cited by Sherri N Rohlf, Julian C Hanson, Carla V Jordan

26 May 2016
21 CFR 312.66

Initial and continuing review

Cited by Sherri N Rohlf, Julian C Hanson, Carla V Jordan

Inspected site

JWJames W. Baker, MDPortland, United States

Inspection team

SNSherri N Rohlf
JCJulian C Hanson
CVCarla V Jordan

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 312.66Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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