Atlas

Form 483

RWJ Barnabas Health-Newark Beth Israel Medical Center - Blood Bank Form 483, 2011-03-21

FDA issued a Form 483 to RWJ Barnabas Health-Newark Beth Israel Medical Center - Blood Bank on 2011-03-21 with 3 public-safe observations.

483· Form 483 issued3 observations

RWJ Barnabas Health-Newark Beth Israel Medical Center - Blood Bank · Newark, United States · Issued March 21, 2011

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

21 Mar 2011
21 CFR 606.60(a)

Equipment observed, standardized, calibrated

Cited by Christina N Maurino

21 Mar 2011
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Christina N Maurino

21 Mar 2011
21 CFR 606.160(b)

Required records

Cited by Christina N Maurino

Inspected site

RBRWJ Barnabas Health-Newark Beth Israel Medical Center - Blood BankNewark, United States

Inspection team

CNChristina N Maurino

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.160(b)Cited across public-safe Form 483 observations1x
21 CFR 606.60(a)Cited 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