# FDA 483 - Catalent Pharma Solutions, LLC - June 14, 2018

Source: https://www.keypedia.com/records/483/catalent-pharma-solutions-llc/c2a346ed-29f8-40bd-88dd-80e5da48f13c

> FDA 483 for Catalent Pharma Solutions, LLC on June 14, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Pharma Solutions, LLC
- Inspection Date: 2018-06-14
- 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, an OTC and prescription drug gel capsule manufacturer, revealed significant deficiencies across production and quality control systems. Observations included failures in preventing microbial contamination, inadequate in-process material inspection, and insufficient review of production and control records. The report also highlighted inconsistent record-keeping and a repeat observation regarding equipment cleaning procedures, indicating a pattern of non-compliance.

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## Related Officers

- [Jennifer Lalama](https://www.keypedia.com/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)
- [Christos G. Tsingelis](https://www.keypedia.com/people/christos-g-tsingelis/a0bacf2c-cf1f-4c34-996a-fcc1aa371610)

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