# FDA 483 - Catalent Indiana, LLC - October 18, 2019

Source: https://www.keypedia.com/records/483/catalent-indiana-llc/ec5f6757-6092-45c5-91a9-9c24e696bac3

> FDA 483 for Catalent Indiana, LLC on October 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Indiana, LLC
- Inspection Date: 2019-10-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Catalent Indiana, LLC, a contract drug manufacturer in Bloomington, IN, was cited for five observations related to significant deficiencies in their manufacturing and quality control processes. These issues include inadequate storage conditions, failure to follow written procedures for visual inspection, insufficient controls to prevent microbiological contamination, and poor equipment maintenance practices. The findings indicate a lack of adherence to cGMP requirements, potentially impacting drug product quality and safety.

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## Related Officers

- [Vaishali J. Patel](https://www.keypedia.com/people/vaishali-j-patel/3d515b84-e0fd-4f96-914c-f7f09e2de307)
- [Investigator](https://www.keypedia.com/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)
- [Jon P. Antoniou](https://www.keypedia.com/people/jon-p-antoniou/e42f4f7d-dbdb-4d85-a755-92cb29c249bc)

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0