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Form 483

Coopervision Manaufacturing, Ltd. Form 483, 2015-09-11

FDA issued a Form 483 to Coopervision Manaufacturing, Ltd. on 2015-09-11 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Coopervision Manaufacturing, Ltd. · Fareham, United Kingdom · Issued September 11, 2015

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.

11 Sep 2015
21 CFR 820.90(b)(1)

Procedures for product review,disposition lack of/inadequate

Cited by James M Odonnell

11 Sep 2015
21 CFR 820.90(b)(1)

Procedures for product review,disposition lack of/inadequate

Cited by James M Odonnell

Inspected site

CMCoopervision Manaufacturing, Ltd.Fareham, United Kingdom

Inspection team

JMJames M Odonnell

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.90(b)(1)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, 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