Atlas

Form 483

Cosman Medical, LLC Form 483, 2016-11-17

FDA issued a Form 483 to Cosman Medical, LLC on 2016-11-17 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Cosman Medical, LLC · Burlington, United States · Issued November 17, 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.

17 Nov 2016
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Justine M Corson

Inspected site

CMCosman Medical, LLCBurlington, United States

Inspection team

JMJustine M Corson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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