Atlas

Form 483

Depuy International Ltd. Form 483, 2012-02-16

FDA issued a Form 483 to Depuy International Ltd. on 2012-02-16 with 2 public-safe observations.

483· Form 483 issued2 observations

Depuy International Ltd. · Leeds, United Kingdom · Issued February 16, 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.

16 Feb 2012
21 CFR 803.52(f)(1)

Type of Reportable Event

Cited by Michael J Nerz

16 Feb 2012
21 CFR 820.20(a)

Management ensuring quality policy is understood

Cited by Michael J Nerz

Inspected site

DIDepuy International Ltd.Leeds, United Kingdom

Inspection team

MJMichael J Nerz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.52(f)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.20(a)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