Atlas

Form 483

University Of Pittsburgh Medical Center Centralized Packaging Form 483, 2009-06-05

FDA issued a Form 483 to University Of Pittsburgh Medical Center Centralized Packaging on 2009-06-05 with 3 public-safe observations.

483· Form 483 issued3 observations

University Of Pittsburgh Medical Center Centralized Packaging · Pittsburgh, United States · Issued June 5, 2009

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

5 Jun 2009
21 CFR 211.67(c)

Cleaning/maintenance records not kept

Cited by Erica L Nicoll

5 Jun 2009
21 CFR 211.68(a)

Written calibration / inspection records not kept

Cited by Erica L Nicoll

5 Jun 2009
21 CFR 211.137(a)

Expiration date lacking

Cited by Erica L Nicoll

Inspected site

UOUniversity Of Pittsburgh Medical Center Centralized PackagingPittsburgh, United States

Inspection team

ELErica L Nicoll

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.137(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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