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Form 483

VertiFlex, Inc. Form 483, 2016-07-19

FDA issued a Form 483 to VertiFlex, Inc. on 2016-07-19 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

VertiFlex, Inc. · San Clemente, United States · Issued July 19, 2016

Overview

  • 2 public-safe observations are 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.

19 Jul 2016
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Jocelyn E Massey

19 Jul 2016
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Jocelyn E Massey

Inspected site

VIVertiFlex, Inc.San Clemente, United States

Inspection team

JEJocelyn E Massey

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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