Atlas

Form 483

RTI Donor Services Form 483, 2014-03-21

FDA issued a Form 483 to RTI Donor Services on 2014-03-21 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

RTI Donor Services · Middleton, United States · Issued March 21, 2014

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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 2014
21 CFR 1271.170(b)

Qualifications lacking

Cited by Susan M Miller

21 Mar 2014
21 CFR 1271.200(b)

Procedures inadequate

Cited by Susan M Miller

Inspected site

RDRTI Donor ServicesMiddleton, United States

Inspection team

SMSusan M Miller

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.170(b)Cited across public-safe Form 483 observations1x
21 CFR 1271.200(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