Form 483

Visionary Contact Lens, Inc. Form 483, 2021-11-10

FDA issued a Form 483 to Visionary Contact Lens, Inc. on 2021-11-10 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Visionary Contact Lens, Inc. · Anaheim, United States · Issued November 10, 2021

Overview

  • 6 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.

10 Nov 2021
21 CFR 820.100(b)

Documentation

Cited by Kevin N Tran

10 Nov 2021
21 CFR 820.100(b)

Documentation

Cited by Kevin N Tran

10 Nov 2021
21 CFR 820.50(a)(2)

Supplier oversight

Cited by Kevin N Tran

10 Nov 2021
21 CFR 820.50(a)(2)

Supplier oversight

Cited by Kevin N Tran

10 Nov 2021
21 CFR 820.75(a)

Documentation

Cited by Kevin N Tran

Inspected site

VCVisionary Contact Lens, Inc.Anaheim, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations2x
21 CFR 820.50(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 820.75(a)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 6 observations

The source PDF, 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