Atlas

Form 483

Rhode Island Blood Center, A Division of New York Blood Center, Inc. Form 483, 2016-11-07

FDA issued a Form 483 to Rhode Island Blood Center, A Division of New York Blood Center, Inc. on 2016-11-07 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Rhode Island Blood Center, A Division of New York Blood Center, Inc. · Providence, United States · Issued November 7, 2016

Overview

  • 2 public-safe observations are 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.

7 Nov 2016
21 CFR 606.160(a)(1)

Concurrent documentation

Cited by Lorayne A Mcguinness

7 Nov 2016
21 CFR 606.160(a)(1)

Concurrent documentation

Cited by Lorayne A Mcguinness

Inspected site

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

Inspection team

LALorayne A Mcguinness

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.160(a)(1)Cited across public-safe Form 483 observations2x

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