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Form 483

Synthes, Inc. Form 483, 2013-11-13

FDA issued a Form 483 to Synthes, Inc. on 2013-11-13 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Synthes, Inc. · West Chester, United States · Issued November 13, 2013

Overview

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

Inspectional observations

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

13 Nov 2013
21 CFR 820.100(b)

Documentation

Cited by Joseph L Despins, Thomas E Friel, Julianne C Mccullough

Inspected site

SISynthes, Inc.West Chester, United States

Inspection team

JLJoseph L Despins
TEThomas E Friel
JCJulianne C Mccullough

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(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