Atlas

Form 483

CooperSurgical, Inc. Form 483, 2013-01-16

FDA issued a Form 483 to CooperSurgical, Inc. on 2013-01-16 with 3 public-safe observations.

483· Form 483 issued3 observations

CooperSurgical, Inc. · Trumbull, United States · Issued January 16, 2013

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

16 Jan 2013
21 CFR 820.30(g)

Design validation - simulated testing

Cited by Michael G Mayfield

16 Jan 2013
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Michael G Mayfield

16 Jan 2013
21 CFR 820.198(c)

Investigation of device failures

Cited by Michael G Mayfield

Inspected site

CICooperSurgical, Inc.Trumbull, United States

Inspection team

MGMichael G Mayfield

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(c)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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