Atlas

Form 483

Rhode Island Blood Center, a Division of New York Blood Center, Inc. Woonsocket Donor Center Form 483, 2017-03-09

FDA issued a Form 483 to Rhode Island Blood Center, a Division of New York Blood Center, Inc. Woonsocket Donor Center on 2017-03-09 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Rhode Island Blood Center, a Division of New York Blood Center, Inc. Woonsocket Donor Center · Woonsocket, United States · Issued March 9, 2017

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.

9 Mar 2017
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Elizabeth B Griffin

Inspected site

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

Inspection team

EBElizabeth B Griffin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)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