Form 483

Collaborative Care Diagnostics, LLC. Form 483, 2016-02-10

FDA issued a Form 483 to Collaborative Care Diagnostics, LLC. on 2016-02-10 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Collaborative Care Diagnostics, LLC. · Eagan, United States · Issued February 10, 2016

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.

10 Feb 2016
21 CFR 820.100(b)

Documentation

Cited by Jennifer S Ness

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x

Full 483 report

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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