# FDA 483 - Catalent Pharma Solutions, LLC - February 22, 2019

Source: https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/c760f7e9-a3ed-4068-8e39-cf085acfd8af

> FDA 483 for Catalent Pharma Solutions, LLC on February 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Pharma Solutions, LLC
- Inspection Date: 2019-02-22
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Catalent Pharma Solutions, LLC in Saint Petersburg, FL, revealed significant deficiencies across their laboratory and production systems. The firm failed to adhere to its written stability testing program, utilized an inadequate dissolution test method for a drug product, and did not follow or properly document written production and process control procedures. These issues indicate a lack of adherence to established quality and manufacturing standards.

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## Related Officers

- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.keypedia.com/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)
- [Ileana Barreto-Petit](https://www.keypedia.com/people/ileana-barreto-petit/e5c865ac-14a2-47d4-954b-464a865e8684)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6