Atlas

Form 483

Michael K. Rosner, M.d. Form 483, 2010-06-03

FDA issued a Form 483 to Michael K. Rosner, M.d. on 2010-06-03 with 2 public-safe observations.

483· Form 483 issued2 observations

Michael K. Rosner, M.d. · Washington, United States · Issued June 3, 2010

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

3 Jun 2010
21 CFR 50.25(a)(2)

Reasonably foreseeable risks or discomforts

Cited by Stephanie L Shapley

3 Jun 2010
21 CFR 812.110(b)

Investigator non-compliance with agreement/plan/regulations

Cited by Stephanie L Shapley

Inspected site

MKMichael K. Rosner, M.d.Washington, United States

Inspection team

SLStephanie L Shapley

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 50.25(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 812.110(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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