Atlas

Form 483

Vivax Medical Corp. Form 483, 2014-03-26

FDA issued a Form 483 to Vivax Medical Corp. on 2014-03-26 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Vivax Medical Corp. · Naugatuck, United States · Issued March 26, 2014

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

26 Mar 2014
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Michael G Mayfield

26 Mar 2014
21 CFR 820.20(c)

Management review - Lack of or inadequate procedures

Cited by Michael G Mayfield

26 Mar 2014
21 CFR 820.30(a)

Design control - no procedures

Cited by Michael G Mayfield

26 Mar 2014
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Michael G Mayfield

26 Mar 2014
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Michael G Mayfield

Inspected site

VMVivax Medical Corp.Naugatuck, United States

Inspection team

MGMichael G Mayfield

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.30(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.72(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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