Atlas

Form 483

Genzyme Corporation Form 483, 2008-10-20

FDA issued a Form 483 to Genzyme Corporation on 2008-10-20 with 2 public-safe observations.

483· Form 483 issued2 observations

Genzyme Corporation · Cambridge, United States · Issued October 20, 2008

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.

20 Oct 2008
21 CFR 312.50

General responsibilities of sponsors

Cited by Michelle M Noe

20 Oct 2008
21 CFR 312.56(b)

Investigator non-compliance

Cited by Michelle M Noe

Inspected site

GCGenzyme CorporationCambridge, United States

Inspection team

MMMichelle M Noe

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations1x
21 CFR 312.56(b)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