# FDA 483 - AGC Biologics SPA - November 20, 2023

Source: https://www.keypedia.com/records/483/agc-biologics-spa/0b914b27-673b-45e5-a09c-3378c61760b7

> FDA 483 for AGC Biologics SPA on November 20, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AGC Biologics SPA
- Inspection Date: 2023-11-20
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: AGC Biologics S.p.A., a cell and gene therapy manufacturer in Bresso, Milan, Italy, was cited for significant deficiencies during an FDA inspection. Observations included a failure to investigate the root cause of repeated non-viable particulate alarms and a lack of adherence to established procedures for handling out-of-action results. Additionally, operators were observed not following aseptic area behavior and hygiene protocols, such as rapid movements and improper glove replacement.

## Related Officers

- [Tiffany Evans](https://www.keypedia.com/people/tiffany-evans/12ca9e67-926c-4947-8632-15b714e4c119)
- [Viviana Ramos](https://www.keypedia.com/people/viviana-ramos/484cad53-13c8-46a3-926b-72e7da168185)
- [Erin C. Hill](https://www.keypedia.com/people/erin-c-hill/74bd0551-2319-46da-933f-5e38469699b6)

Company: https://www.keypedia.com/companies/agc-biologics-spa/aca43856-193e-492b-9512-0f72b2680e90

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd