Atlas

Form 483

Nikomed USA, Inc Form 483, 2017-02-06

FDA issued a Form 483 to Nikomed USA, Inc on 2017-02-06 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Nikomed USA, Inc · Hatboro, United States · Issued February 6, 2017

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.

6 Feb 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Raffi B Papazian

6 Feb 2017
21 CFR 820.100(b)

Documentation

Cited by Raffi B Papazian

6 Feb 2017
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Raffi B Papazian

Inspected site

NUNikomed USA, IncHatboro, United States

Inspection team

RBRaffi B Papazian

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)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