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483
•Vero Biotech Inc•October 24, 2019

Vero Biotech Inc – FDA 483, Oct 24, 2019

Record Details

An FDA inspection of Vero Biotech, LLC in Atlanta, GA, revealed two significant observations. The firm was cited for inadequate written procedures for its quality control unit, specifically regarding rework activities and limits. Additionally, deviations from production and process control procedures were not justified, as evidenced by an equipment IOQ failure that was deemed passing without a root cause analysis.

Company
Vero Biotech Inc
Inspection date
October 24, 2019
Product type
drugs
Office
Atlanta District Office
People
  • Veronica Fuentes (Pharmaceutical Specialist/ Investigator )
  • Laurie A. Nelson
View Company Profile

ID · 198ba66d-8e58-4684-8761-d3efbbf0e093

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