Form 483

Hill-Rom, Inc. Form 483, 2017-06-22

FDA issued a Form 483 to Hill-Rom, Inc. on 2017-06-22 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Hill-Rom, Inc. · Raleigh, United States · Issued June 22, 2017

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

22 Jun 2017
21 CFR 820.170(b)

Installer records

Cited by Samuel L Murray, Trang N Cox

22 Jun 2017
21 CFR 820.170(b)

Installer records

Cited by Samuel L Murray, Trang N Cox

22 Jun 2017
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Samuel L Murray, Trang N Cox

22 Jun 2017
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Samuel L Murray, Trang N Cox

Inspected site

HIHill-Rom, Inc.Raleigh, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.170(b)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x

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