Atlas

Form 483

Cenogenics Corporation Form 483, 2017-10-17

FDA issued a Form 483 to Cenogenics Corporation on 2017-10-17 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Cenogenics Corporation · Morganville, United States · Issued October 17, 2017

Overview

  • 6 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.

17 Oct 2017
21 CFR 820.100(b)

Documentation

Cited by Gobiga Vanniyasingam

17 Oct 2017
21 CFR 820.100(b)

Documentation

Cited by Gobiga Vanniyasingam

17 Oct 2017
21 CFR 820.184

DHR content

Cited by Gobiga Vanniyasingam

17 Oct 2017
21 CFR 820.184

DHR content

Cited by Gobiga Vanniyasingam

17 Oct 2017
21 CFR 820.198(e)

Records of complaint investigation

Cited by Gobiga Vanniyasingam

Inspected site

CCCenogenics CorporationMorganville, United States

Inspection team

GVGobiga Vanniyasingam

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations2x
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.198(e)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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