Atlas

Form 483

Rhode Island Blood Center, A Division of New York Blood Center, Inc. Form 483, 2011-09-27

FDA issued a Form 483 to Rhode Island Blood Center, A Division of New York Blood Center, Inc. on 2011-09-27 with 2 public-safe observations.

483· Form 483 issued2 observations

Rhode Island Blood Center, A Division of New York Blood Center, Inc. · Providence, United States · Issued September 27, 2011

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

27 Sep 2011
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Kent A Conforti, Lorayne A Mcguinness

27 Sep 2011
21 CFR 606.160(b)

Required records

Cited by Kent A Conforti, Lorayne A Mcguinness

Inspected site

RIRhode Island Blood Center, A Division of New York Blood Center, Inc.Providence, United States

Inspection team

KAKent A Conforti
LALorayne A Mcguinness

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)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 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