Atlas

Form 483

Viscot Medical LLC Form 483, 2011-05-16

FDA issued a Form 483 to Viscot Medical LLC on 2011-05-16 with 3 public-safe observations.

483· Form 483 issued3 observations

Viscot Medical LLC · East Hanover, United States · Issued May 16, 2011

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.

16 May 2011
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Kristen E Rescigno

16 May 2011
21 CFR 820.75(b)

Lack/Inad procedure-Monitoring/Control of Validated Proces

Cited by Kristen E Rescigno

16 May 2011
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Kristen E Rescigno

Inspected site

VMViscot Medical LLCEast Hanover, United States

Inspection team

KEKristen E Rescigno

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 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(b)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