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Form 483

CooperSurgical, Inc. Form 483, 2012-05-23

FDA issued a Form 483 to CooperSurgical, Inc. on 2012-05-23 with 2 public-safe observations.

483· Form 483 issued2 observations

CooperSurgical, Inc. · North Tonawanda, United States · Issued May 23, 2012

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

23 May 2012
21 CFR 211.170(b)

Reserve samples identified, representative, stored

Cited by Karen L Kosar, David A Carlson

23 May 2012
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Karen L Kosar, David A Carlson

Inspected site

CICooperSurgical, Inc.North Tonawanda, United States

Inspection team

KLKaren L Kosar
DADavid A Carlson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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