Atlas

Form 483

Inside Track Cabling, Inc Form 483, 2013-07-26

FDA issued a Form 483 to Inside Track Cabling, Inc on 2013-07-26 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Inside Track Cabling, Inc · Hudson, United States · Issued July 26, 2013

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

26 Jul 2013
21 CFR 820.20(c)

Management review - defined interval, sufficient frequency

Cited by Abby E Pelletier

26 Jul 2013
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Abby E Pelletier

26 Jul 2013
21 CFR 820.50(a)(3)

Acceptable supplier records, inadequate records

Cited by Abby E Pelletier

26 Jul 2013
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Abby E Pelletier

Inspected site

ITInside Track Cabling, IncHudson, United States

Inspection team

AEAbby E Pelletier

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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