Atlas

Form 483

Roswell Park Cancer Institute Corporation. Div. of Pathology Form 483, 2011-06-17

FDA issued a Form 483 to Roswell Park Cancer Institute Corporation. Div. of Pathology on 2011-06-17 with 4 public-safe observations.

483· Form 483 issued4 observations

Roswell Park Cancer Institute Corporation. Div. of Pathology · Buffalo, United States · Issued June 17, 2011

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

17 Jun 2011
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Evelyn Taha

17 Jun 2011
21 CFR 211.194(a)(7)

Signatures and dates--person who performs test

Cited by Evelyn Taha

17 Jun 2011
21 CFR 211.194(a)(8)

Second person sign off

Cited by Evelyn Taha

17 Jun 2011
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Evelyn Taha

Inspected site

RPRoswell Park Cancer Institute Corporation. Div. of PathologyBuffalo, United States

Inspection team

ETEvelyn Taha

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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