Atlas

Form 483

Zimmer Manufacturing B.V. Form 483, 2017-07-20

FDA issued a Form 483 to Zimmer Manufacturing B.V. on 2017-07-20 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Zimmer Manufacturing B.V. · Mercedita, United States · Issued July 20, 2017

Overview

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

Inspectional observations

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

20 Jul 2017
21 CFR 820.100(b)

Documentation

Cited by Adaliz Santaliz-Cruz, Phillip M Pontikos, Bleta Vuniqi

20 Jul 2017
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Adaliz Santaliz-Cruz, Phillip M Pontikos, Bleta Vuniqi

20 Jul 2017
21 CFR 820.75(b)

Lack/Inad procedure-Monitoring/Control of Validated Proces

Cited by Adaliz Santaliz-Cruz, Phillip M Pontikos, Bleta Vuniqi

Inspected site

ZMZimmer Manufacturing B.V.Mercedita, United States

Inspection team

ASAdaliz Santaliz-Cruz
PMPhillip M Pontikos
BVBleta Vuniqi

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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