# FDA 483 - Catalent Belgium SA - June 19, 2019

Source: https://www.keypedia.com/records/483/catalent-belgium-sa/0bdc03da-0772-4c63-92a1-bf5a5e92ae50

> FDA 483 for Catalent Belgium SA on June 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Belgium SA
- Inspection Date: 2019-06-19
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Catalent Belgium SA, a manufacturer of sterile drug products in Brussels, revealed significant deficiencies. Observations included inadequate procedures to prevent microbiological contamination, insufficient control procedures for manufacturing processes, and incomplete laboratory records. These issues indicate potential risks to product quality and integrity.

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## Related Officers

- [CSO](https://www.keypedia.com/people/mihaly-s-ligmond/2904ef70-a757-49c7-9ac4-a2c07ee36001)

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

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321