Atlas

Form 483

Genzyme Ireland Limited Form 483, 2017-06-16

FDA issued a Form 483 to Genzyme Ireland Limited on 2017-06-16 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Genzyme Ireland Limited · Waterford, Ireland · Issued June 16, 2017

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

16 Jun 2017
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Scott T Ballard, Wayne E Seifert

16 Jun 2017
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Scott T Ballard, Wayne E Seifert

16 Jun 2017
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Scott T Ballard, Wayne E Seifert

16 Jun 2017
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Scott T Ballard, Wayne E Seifert

Inspected site

GIGenzyme Ireland LimitedWaterford, Ireland

Inspection team

STScott T Ballard
WEWayne E Seifert

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x

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