# FDA 483 - Catalent Indiana, LLC - May 19, 2017

Source: https://www.keypedia.com/records/483/catalent-indiana-llc/c94fcb22-4859-42f4-9a11-cfb8abea6118

> FDA 483 for Catalent Indiana, LLC on May 19, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Indiana, LLC
- Inspection Date: 2017-05-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Cook Pharmica, LLC in Bloomington, IN was inspected and received a Form 483 with six observations related to significant deficiencies in their quality system, production, process controls, and CAPA procedures. The firm failed to adequately follow and document procedures for quality control, production, and process validation, particularly concerning Class II In Vitro Fertilization Reproductive Media devices. Additionally, issues were noted with vendor complaint initiation and the establishment of effective corrective and preventive actions.

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

## Related Officers

- [Associate Director](https://www.keypedia.com/people/jeffrey-d-meng/55543677-bd74-4cc5-8a2a-e14afb91d338)
- [investigator](https://www.keypedia.com/people/sargum-c-sood/980cd904-0fac-488d-8ea9-39a44d8ea21d)
- [Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality](https://www.keypedia.com/people/emilie-e-kahn/fac179e5-478f-4e75-9632-40d921f44a8f)

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