Atlas

Form 483

United Contact Lens, Inc. Form 483, 2011-06-15

FDA issued a Form 483 to United Contact Lens, Inc. on 2011-06-15 with 2 public-safe observations.

483· Form 483 issued2 observations

United Contact Lens, Inc. · Arlington, United States · Issued June 15, 2011

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

15 Jun 2011
21 CFR 820.72(a)

Calibration, Inspection, etc. Procedures Lack of or Inadequ

Cited by Stephen R Souza

15 Jun 2011
21 CFR 820.80(c)

Lack of or inadequate In-process acceptance procedures

Cited by Stephen R Souza

Inspected site

UCUnited Contact Lens, Inc.Arlington, United States

Inspection team

SRStephen R Souza

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.72(a)Cited across public-safe Form 483 observations1x
21 CFR 820.80(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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