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Form 483

Roswell Park Cancer Institute Form 483, 2014-01-23

FDA issued a Form 483 to Roswell Park Cancer Institute on 2014-01-23 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Roswell Park Cancer Institute · Buffalo, United States · Issued January 23, 2014

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.

23 Jan 2014
21 CFR 56.107(e)

Conflict of interest

Cited by Karen L Kosar

Inspected site

RPRoswell Park Cancer InstituteBuffalo, United States

Inspection team

KLKaren L Kosar

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.107(e)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 1 observation

The source PDF and 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