Atlas

Form 483

Old Dominion Eye Foundation, Inc. Northern Virginia Branch Form 483, 2016-08-24

FDA issued a Form 483 to Old Dominion Eye Foundation, Inc. Northern Virginia Branch on 2016-08-24 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Old Dominion Eye Foundation, Inc. Northern Virginia Branch · Manassas, United States · Issued August 24, 2016

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.

24 Aug 2016
21 CFR 1271.200(c)

Calibrated per established schedules

Cited by La-Tasha M Gunter

24 Aug 2016
21 CFR 1271.260(e)

Storage temperatures recorded, maintained

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 1271.200(c)Cited across public-safe Form 483 observations1x
21 CFR 1271.260(e)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