Form 483

Health Net Connect Inc Form 483, 2016-04-06

FDA issued a Form 483 to Health Net Connect Inc on 2016-04-06 with 12 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health12 observations

Health Net Connect Inc · Wixom, United States · Issued April 6, 2016

Overview

  • 12 public-safe observations are available for this inspection.
  • 6 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.

6 Apr 2016
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Deanna L Lampley

6 Apr 2016
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Deanna L Lampley

6 Apr 2016
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Deanna L Lampley

6 Apr 2016
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Deanna L Lampley

6 Apr 2016
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Deanna L Lampley

Inspected site

HNHealth Net Connect IncWixom, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations2x
21 CFR 820.181Cited across public-safe Form 483 observations2x
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.30(a)Cited across public-safe Form 483 observations2x
21 CFR 820.40Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 12 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