Atlas

Form 483

Rhode Island Blood Center, a Division of New York Blood Center, Inc. Woonsocket Donor Center Form 483, 2011-10-28

FDA issued a Form 483 to Rhode Island Blood Center, a Division of New York Blood Center, Inc. Woonsocket Donor Center on 2011-10-28 with 3 public-safe observations.

483· Form 483 issued3 observations

Rhode Island Blood Center, a Division of New York Blood Center, Inc. Woonsocket Donor Center · Woonsocket, United States · Issued October 28, 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.

28 Oct 2011
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Alice C Silva

28 Oct 2011
21 CFR 606.100(b)(21)

Donor notification

Cited by Alice C Silva

28 Oct 2011
21 CFR 606.160(b)

Required records

Cited by Alice C Silva

Inspected site

RIRhode Island Blood Center, a Division of New York Blood Center, Inc. Woonsocket Donor CenterWoonsocket, United States

Inspection team

ACAlice C Silva

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 606.100(b)(21)Cited across public-safe Form 483 observations1x
21 CFR 606.160(b)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