Atlas

Form 483

Old Dominion Eye Foundation, Inc. Northern Virginia Branch Form 483, 2012-06-06

FDA issued a Form 483 to Old Dominion Eye Foundation, Inc. Northern Virginia Branch on 2012-06-06 with 3 public-safe observations.

483· Form 483 issued3 observations

Old Dominion Eye Foundation, Inc. Northern Virginia Branch · Manassas, United States · Issued June 6, 2012

Overview

  • 3 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.

6 Jun 2012
21 CFR 1271.180(a)

Procedures to meet core CTGP

Cited by La-Tasha M Gunter

6 Jun 2012
21 CFR 1271.200(b)

Procedures inadequate

Cited by La-Tasha M Gunter

6 Jun 2012
21 CFR 1271.200(c)

Calibration procedures and schedules (general)

Cited by La-Tasha M Gunter

Inspected site

ODOld Dominion Eye Foundation, Inc. Northern Virginia BranchManassas, United States

Inspection team

LMLa-Tasha M Gunter

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.180(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.200(b)Cited across public-safe Form 483 observations1x
21 CFR 1271.200(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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