# FDA 483 - Catalent Indiana, LLC - May 12, 2023

Source: https://www.keypedia.com/records/483/catalent-indiana-llc/cb5f6217-8e32-4cb5-92c6-804a2a97c412

> FDA 483 for Catalent Indiana, LLC on May 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Indiana, LLC
- Inspection Date: 2023-05-12
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Catalent Indiana, LLC in Bloomington, IN, was cited for significant deficiencies during an FDA inspection. The observations primarily concern failures to follow or establish written production and process control procedures, inadequate equipment revalidation, and poor maintenance and cleaning of equipment and facilities. These issues indicate a lack of control over aseptic processing and overall facility integrity, posing potential risks to product quality and sterility.

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## Related Officers

- [Esther C. Hovter](https://www.keypedia.com/people/esther-c-hovter/43905846-e492-4b98-8a38-74308cd9551c)
- [Hyung-yul Lee](https://www.keypedia.com/people/hyung-yul-lee/a790a804-2e43-4901-8d7d-0c656c464f0f)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/catalent-indiana-llc/3422c8c4-978a-45ba-962b-b00002fffd6d

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