Atlas

Form 483

Hanuri Distribution Inc Form 483, 2016-11-09

FDA issued a Form 483 to Hanuri Distribution Inc on 2016-11-09 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Hanuri Distribution Inc · Chatsworth, United States · Issued November 9, 2016

Overview

  • 3 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.

9 Nov 2016
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Sarah A Hassas

9 Nov 2016
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Sarah A Hassas

9 Nov 2016
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by Sarah A Hassas

Inspected site

HDHanuri Distribution IncChatsworth, United States

Inspection team

SASarah A Hassas

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.198(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 3 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