Atlas

Form 483

Cardiva Medical, Inc. Form 483, 2017-05-10

FDA issued a Form 483 to Cardiva Medical, Inc. on 2017-05-10 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Cardiva Medical, Inc. · Santa Clara, United States · Issued May 10, 2017

Overview

  • 2 public-safe observations are 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 May 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jude C Dike

10 May 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jude C Dike

Inspected site

CMCardiva Medical, Inc.Santa Clara, United States

Inspection team

JCJude C Dike

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 2 observations

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