# FDA 483 - Catalent Indiana, LLC - September 01, 2022

Source: https://www.keypedia.com/records/483/catalent-indiana-llc/d93759b0-6517-4cd1-8722-bb2bfdf4f02b

> FDA 483 for Catalent Indiana, LLC on September 01, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Indiana, LLC
- Inspection Date: 2022-09-01
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Catalent Indiana, LLC in Bloomington, IN, revealed significant deficiencies in the manufacturing of sterile human drug and biologic products. The firm failed to thoroughly investigate discrepancies, adequately handle complaints, ensure proper equipment design and validation, and maintain robust aseptic processing controls. These issues indicate a systemic lack of adherence to quality standards and pose potential risks to product quality and sterility.

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## Related Officers

- [Eboni Funderburk, Investigator](https://www.keypedia.com/people/eboni-funderburk-investigator/315ae5a8-b9ba-4cf3-9b70-f8785e281519)
- [Muna Algharibeh, Investigator](https://www.keypedia.com/people/muna-algharibeh-investigator/3d34b29f-34a3-4b51-98b0-158735043176)
- [Logan Williams, Investigator](https://www.keypedia.com/people/logan-williams-investigator/c5a44926-1999-4e35-bb10-d47d9b22e8bc)
- [Sandra Boyd, National Expert](https://www.keypedia.com/people/sandra-boyd-national-expert/d086b47b-0ede-4d68-9f37-2c5d4ee5b12e)

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