# FDA 483 - Catalent Belgium SA - Unknown Date

Source: https://www.keypedia.com/records/483/catalent-belgium-sa/8c3c7fa7-4d02-435e-bfa7-eca8c01018fd

> FDA 483 for Catalent Belgium SA on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Belgium SA
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Catalent Belgium SA revealed significant deficiencies in their manufacturing processes for sterile drug products. Observations included a lack of established procedures for handling media fill failures, inadequate adherence to good documentation practices by the quality control unit, and insufficient controls over computer systems allowing unauthorized data manipulation. Additionally, the firm failed to establish the accuracy and reproducibility of certain analytical test methods.

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## Related Officers

- [Business Owner](https://www.keypedia.com/people/james-whitney/072bf37e-a5c6-41bb-b0c1-1f944b112b43)
- [Market Manager](https://www.keypedia.com/people/lisa-orr/1a0fd214-ce6e-4841-bf52-2fe4239e328a)
- [investigator](https://www.keypedia.com/people/youmin-wang/a61763d9-5354-4e2f-9909-d2bacdd5c34d)

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