Atlas

Form 483

Division of Nuclear Medicine PET Radiopharmaceutical Production Program Form 483, 2014-02-21

FDA issued a Form 483 to Division of Nuclear Medicine PET Radiopharmaceutical Production Program on 2014-02-21 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Division of Nuclear Medicine PET Radiopharmaceutical Production Program · Ann Arbor, United States · Issued February 21, 2014

Overview

  • 1 public-safe observation is 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 Feb 2014
21 CFR 212.20(d)

Determination need for investigation

Cited by Rebecca E Dombrowski

Inspected site

DODivision of Nuclear Medicine PET Radiopharmaceutical Production ProgramAnn Arbor, United States

Inspection team

RERebecca E Dombrowski

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 212.20(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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