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Form 483

Surmodics Inc Form 483, 2021-11-04

FDA issued a Form 483 to Surmodics Inc on 2021-11-04 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Surmodics Inc · Eden Prairie, United States · Issued November 4, 2021

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

4 Nov 2021
21 CFR 812.140(b)(2)

Sponsor device disposition records inadequate

Cited by Denise L Burosh

Inspected site

SISurmodics IncEden Prairie, United States

Inspection team

DLDenise L Burosh

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 812.140(b)(2)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

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The source PDF, 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