Atlas

Form 483

Fresenius Medical Care Holdings, Inc. Form 483, 2018-01-12

FDA issued a Form 483 to Fresenius Medical Care Holdings, Inc. on 2018-01-12 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Fresenius Medical Care Holdings, Inc. · Waltham, United States · Issued January 12, 2018

Overview

  • 4 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.

12 Jan 2018
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Stephen C Smith

12 Jan 2018
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Stephen C Smith

12 Jan 2018
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Stephen C Smith

12 Jan 2018
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Stephen C Smith

Inspected site

FMFresenius Medical Care Holdings, Inc.Waltham, United States

Inspection team

SCStephen C Smith

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 4 observations

The source PDF and 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