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Form 483

Medtronic Puerto Rico Operations Co. Form 483, 2019-02-21

FDA issued a Form 483 to Medtronic Puerto Rico Operations Co. on 2019-02-21 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Medtronic Puerto Rico Operations Co. · Juncos, United States · Issued February 21, 2019

Overview

  • 3 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.

21 Feb 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Adaliz Santaliz-Cruz

21 Feb 2019
21 CFR 820.198(c)

Investigation of device failures

Cited by Adaliz Santaliz-Cruz

21 Feb 2019
21 CFR 820.198(c)

Investigation of device failures

Cited by Adaliz Santaliz-Cruz

Inspected site

MPMedtronic Puerto Rico Operations Co.Juncos, United States

Inspection team

ASAdaliz Santaliz-Cruz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(c)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x

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 3 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