Atlas

Form 483

Metrowest Medical Center-Framingham Campus Form 483, 2012-09-12

FDA issued a Form 483 to Metrowest Medical Center-Framingham Campus on 2012-09-12 with 2 public-safe observations.

483· Form 483 issued2 observations

Metrowest Medical Center-Framingham Campus · Framingham, United States · Issued September 12, 2012

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.

12 Sep 2012
21 CFR 606.100(b)(1)

Donor criteria

Cited by Alice C Silva

12 Sep 2012
21 CFR 606.100(b)(21)

Donor notification

Cited by Alice C Silva

Inspected site

MMMetrowest Medical Center-Framingham CampusFramingham, United States

Inspection team

ACAlice C Silva

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 606.100(b)(21)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