Atlas

Form 483

ConMed Corporation Form 483, 2014-07-18

FDA issued a Form 483 to ConMed Corporation on 2014-07-18 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

ConMed Corporation · Utica, United States · Issued July 18, 2014

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

18 Jul 2014
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Nicholas C Mendiola, Jeanette L Mcginnis

18 Jul 2014
21 CFR 820.72(a)

Equipment control activity documentation

Cited by Nicholas C Mendiola, Jeanette L Mcginnis

18 Jul 2014
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Nicholas C Mendiola, Jeanette L Mcginnis

Inspected site

CCConMed CorporationUtica, United States

Inspection team

NCNicholas C Mendiola
JLJeanette L Mcginnis

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.72(a)Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)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