Atlas

Form 483

Anzacare Ltd Form 483, 2017-05-18

FDA issued a Form 483 to Anzacare Ltd on 2017-05-18 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Anzacare Ltd · Waikanae, New Zealand · Issued May 18, 2017

Overview

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

18 May 2017
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Cynthia T Cain

18 May 2017
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Cynthia T Cain

18 May 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Cynthia T Cain

18 May 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Cynthia T Cain

18 May 2017
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Cynthia T Cain

Inspected site

ALAnzacare LtdWaikanae, New Zealand

Inspection team

CTCynthia T Cain

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.184Cited across public-safe Form 483 observations2x

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