Atlas

Form 483

Robert Wood Johnson University Hospital Somerset Form 483, 2011-04-14

FDA issued a Form 483 to Robert Wood Johnson University Hospital Somerset on 2011-04-14 with 2 public-safe observations.

483· Form 483 issued2 observations

Robert Wood Johnson University Hospital Somerset · Somerville, United States · Issued April 14, 2011

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.

14 Apr 2011
21 CFR 606.100(b)(14)

QC procedures for supplies and reagents

Cited by Christina N Maurino

14 Apr 2011
21 CFR 606.171

Biological product deviation report

Cited by Christina N Maurino

Inspected site

RWRobert Wood Johnson University Hospital SomersetSomerville, United States

Inspection team

CNChristina N Maurino

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)(14)Cited across public-safe Form 483 observations1x
21 CFR 606.171Cited 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