Form 483

MSD Ireland (Carlow) Form 483, 2017-02-21

FDA issued a Form 483 to MSD Ireland (Carlow) on 2017-02-21 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

MSD Ireland (Carlow) · Carlow, Ireland · Issued February 21, 2017

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

21 Feb 2017
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Junho Pak

Inspected site

MIMSD Ireland (Carlow)Carlow, Ireland

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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