Atlas

Form 483

Hanuri Distribution Inc Form 483, 2013-12-09

FDA issued a Form 483 to Hanuri Distribution Inc on 2013-12-09 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Hanuri Distribution Inc · Chatsworth, United States · Issued December 9, 2013

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

9 Dec 2013
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Kelvin Cheung

9 Dec 2013
21 CFR 820.40

Lack of procedures, or not maintained

Cited by Kelvin Cheung

9 Dec 2013
21 CFR 820.72(a)

Equipment control activity documentation

Cited by Kelvin Cheung

9 Dec 2013
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by Kelvin Cheung

Inspected site

HDHanuri Distribution IncChatsworth, United States

Inspection team

KCKelvin Cheung

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.72(a)Cited across public-safe Form 483 observations1x
21 CFR 820.80(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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