# FDA 483 - Catalent Belgium SA - July 12, 2024

Source: https://www.keypedia.com/records/483/catalent-belgium-sa/95dfaf1f-b957-49b3-84a4-d94cf642abc4

> FDA 483 for Catalent Belgium SA on July 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Belgium SA
- Inspection Date: 2024-07-12
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Catalent Belgium, S.A. revealed significant deficiencies in aseptic processing, environmental monitoring, and facility maintenance. The firm failed to establish and follow adequate procedures to prevent microbial contamination, conduct representative aseptic process simulations, and properly control its manufacturing processes. These issues indicate a high risk to drug product quality and sterility, compounded by inadequate facility upkeep and procedural non-compliance.

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## Related Officers

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Company: https://www.keypedia.com/companies/catalent-belgium-sa/f48653bf-84a2-4aeb-bdc3-ca2d0cc4fdf2

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