Atlas

Form 483

UMASS Memorial Medical Center, Inc. Form 483, 2009-09-02

FDA issued a Form 483 to UMASS Memorial Medical Center, Inc. on 2009-09-02 with 2 public-safe observations.

483· Form 483 issued2 observations

UMASS Memorial Medical Center, Inc. · Worcester, United States · Issued September 2, 2009

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.

2 Sep 2009
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Kent A Conforti

2 Sep 2009
21 CFR 606.100(c)

Record review prior to release

Cited by Kent A Conforti

Inspected site

UMUMASS Memorial Medical Center, Inc.Worcester, United States

Inspection team

KAKent A Conforti

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)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