Atlas

Form 483

ASCENSIA DIABETES CARE US INC. Form 483, 2015-09-18

FDA issued a Form 483 to ASCENSIA DIABETES CARE US INC. on 2015-09-18 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

ASCENSIA DIABETES CARE US INC. · Parsippany, United States · Issued September 18, 2015

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.

18 Sep 2015
21 CFR 812.100

Investigator non-compliance with agreement/plan/regulations

Cited by Peter R Lenahan

18 Sep 2015
21 CFR 812.40

Sponsors' general responsibilities

Cited by Peter R Lenahan

Inspected site

ADASCENSIA DIABETES CARE US INC.Parsippany, United States

Inspection team

PRPeter R Lenahan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 812.100Cited across public-safe Form 483 observations1x
21 CFR 812.40Cited 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