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Form 483

Covidien, LP Form 483, 2017-11-15

FDA issued a Form 483 to Covidien, LP on 2017-11-15 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Covidien, LP · Norfolk, United States · Issued November 15, 2017

Overview

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

Inspectional observations

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

15 Nov 2017
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Eric C Fox, Eric M Padgett

15 Nov 2017
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Eric C Fox, Eric M Padgett

Inspected site

CLCovidien, LPNorfolk, United States

Inspection team

ECEric C Fox
EMEric M Padgett

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
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.

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Full 483 report

Get the verbatim text of all 2 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