# FDA 483 - Catalent Indiana, LLC - Unknown Date

Source: https://www.keypedia.com/records/483/catalent-indiana-llc/ea1520cb-3d0a-46f2-abdd-5e80b6c0d3a1

> FDA 483 for Catalent Indiana, LLC on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Indiana, LLC
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Catalent Biologics, Catalent Indiana, LLC in Bloomington, IN, a drug product manufacturer, was cited for failing to follow procedures designed to prevent microbiological contamination of sterile drug products. Inspectors observed poor aseptic techniques during setup and fill operations, including improper operator movement, lack of sanitization during interventions, and inadequate protection of equipment from contamination. These findings indicate a significant concern regarding the sterility assurance of their drug products.

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- [483 - Unknown Date](https://www.keypedia.com/records/483/catalent-indiana-llc/70255023-0dba-4473-a659-64d38a7df3ea)

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

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