Atlas

Form 483

Volk Optical Inc Form 483, 2012-10-24

FDA issued a Form 483 to Volk Optical Inc on 2012-10-24 with 1 public-safe observation.

483· Form 483 issued1 observation

Volk Optical Inc · Mentor, United States · Issued October 24, 2012

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.

24 Oct 2012
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Brigitte K Hofmann

Inspected site

VOVolk Optical IncMentor, United States

Inspection team

BKBrigitte K Hofmann

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x

Full 483 report

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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