Atlas

Form 483

Nikomed USA, Inc Form 483, 2008-10-09

FDA issued a Form 483 to Nikomed USA, Inc on 2008-10-09 with 4 public-safe observations.

483· Form 483 issued4 observations

Nikomed USA, Inc · Hatboro, United States · Issued October 9, 2008

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

9 Oct 2008
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Matthew R Noonan, Michael J Nerz

9 Oct 2008
21 CFR 820.20(b)(3)

Management representative

Cited by Matthew R Noonan, Michael J Nerz

9 Oct 2008
21 CFR 820.100(a)(1)

Analysis of data sources

Cited by Matthew R Noonan, Michael J Nerz

9 Oct 2008
21 CFR 820.198(c)

Investigation of device failures

Cited by Matthew R Noonan, Michael J Nerz

Inspected site

NUNikomed USA, IncHatboro, United States

Inspection team

MRMatthew R Noonan
MJMichael J Nerz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.198(c)Cited across public-safe Form 483 observations1x
21 CFR 820.20(b)(3)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