# FDA 483 - Catalent Pharma Solutions, LLC - July 21, 2023

Source: https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/b53d3803-0505-4856-999c-33b3e1fb1bda

> FDA 483 for Catalent Pharma Solutions, LLC on July 21, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Catalent Pharma Solutions, LLC
- Inspection Date: 2023-07-21
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Catalent Pharma Solutions, LLC, a dietary supplement manufacturer in Saint Petersburg, FL, received an FDA Form 483 for multiple significant deficiencies observed during an inspection. The firm failed to establish adequate specifications for components, finished products, and labels, and exhibited issues with master manufacturing records, batch production records, and equipment sanitation. These findings indicate a lack of control over critical aspects of dietary supplement manufacturing.

## Related Documents

- [483 - 2016-03-25](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/70f13562-b3ef-4e98-aae6-b2b576bd35e7)
- [483 - 2018-06-14](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/c2a346ed-29f8-40bd-88dd-80e5da48f13c)
- [483 - 2019-02-22](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/c760f7e9-a3ed-4068-8e39-cf085acfd8af)
- [483 - 2026-01-30](https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/93c4cc9c-fd83-4c26-9023-0b4c62c93c56)

## Related Officers

- [Lourdes Andujar](https://www.keypedia.com/people/lourdes-andujar/974f57ac-d5ee-4432-9fa7-a873145432ed)
- [Moraima J. Ramos-Valle](https://www.keypedia.com/people/moraima-j-ramos-valle/b6f133ec-d445-4563-babd-abd331b7b09d)
- [Jose E. Perez-Soto](https://www.keypedia.com/people/jose-e-perez-soto/d7d8e54c-48ba-4bb6-be7d-974782433968)

Company: https://www.keypedia.com/companies/catalent-pharma-solutions-llc/d29a124f-fdcb-4108-9eac-661149b4d20e

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6