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Form 483

Dravon Medical, Inc. Form 483, 2014-03-21

FDA issued a Form 483 to Dravon Medical, Inc. on 2014-03-21 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Dravon Medical, Inc. · Clackamas, United States · Issued March 21, 2014

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.

21 Mar 2014
21 CFR 820.90(b)(1)

Procedures for product review,disposition lack of/inadequate

Cited by Stanley B Eugene

21 Mar 2014
21 CFR 820.100(b)

Documentation

Cited by Stanley B Eugene

Inspected site

DMDravon Medical, Inc.Clackamas, United States

Inspection team

SBStanley B Eugene

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 820.90(b)(1)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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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