Atlas

Form 483

Nikomed USA, Inc Form 483, 2011-12-01

FDA issued a Form 483 to Nikomed USA, Inc on 2011-12-01 with 2 public-safe observations.

483· Form 483 issued2 observations

Nikomed USA, Inc · Hatboro, United States · Issued December 1, 2011

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

1 Dec 2011
21 CFR 820.20(a)

Management ensuring quality policy is understood

Cited by Michael J Nerz

1 Dec 2011
21 CFR 820.50(a)

Evaluation of suppliers, contractors, etc., requirements

Cited by Michael J Nerz

Inspected site

NUNikomed USA, IncHatboro, United States

Inspection team

MJMichael J Nerz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.20(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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