# FDA 483 - Vero Biotech Inc - October 24, 2019

Source: https://www.keypedia.com/records/483/vero-biotech-inc/198ba66d-8e58-4684-8761-d3efbbf0e093

> FDA 483 for Vero Biotech Inc on October 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vero Biotech Inc
- Inspection Date: 2019-10-24
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: 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.

## Related Officers

- [Pharmaceutical Specialist/ Investigator ](https://www.keypedia.com/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)
- [Laurie A. Nelson](https://www.keypedia.com/people/laurie-a-nelson/dbd373d1-ce1f-486c-a932-d93f8f52832d)

Company: https://www.keypedia.com/companies/vero-biotech-inc/1a8e249a-9cc3-490b-987d-48d82a4e643f

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7