Atlas

Form 483

Laboratory Corporation of America ViroMed Laboratories Form 483, 2013-06-24

FDA issued a Form 483 to Laboratory Corporation of America ViroMed Laboratories on 2013-06-24 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Laboratory Corporation of America ViroMed Laboratories · Burlington, United States · Issued June 24, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 4 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

24 Jun 2013
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Sandra Sejdinovic, Kellie L Thommes, Melissa D Kalik, Jessica L Johnson

24 Jun 2013
21 CFR 1271.80(c)

Manufacturer instructions not followed

Cited by Sandra Sejdinovic, Kellie L Thommes, Melissa D Kalik, Jessica L Johnson

Inspected site

LCLaboratory Corporation of America ViroMed LaboratoriesBurlington, United States

Inspection team

SSSandra Sejdinovic
KLKellie L Thommes
MDMelissa D Kalik
JLJessica L Johnson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.47(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.80(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