# FDA 483 - Padagis US LLC - September 06, 2024

Source: https://www.keypedia.com/records/483/padagis-us-llc/f48ce613-ab89-48a6-b71d-008539b67ebf

> FDA 483 for Padagis US LLC on September 06, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Padagis US LLC
- Inspection Date: 2024-09-06
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Padagis US LLC in Minneapolis, MN, a drug manufacturer, revealed deficiencies in equipment cleaning and maintenance procedures. Specifically, the firm failed to demonstrate the effectiveness of an un-validated cleaning procedure for a tank mixer used for drug components, including 'at-risk' ingredients. This indicates a significant concern regarding potential contamination and product quality.

## Related Officers

- [Beatrix D. Hippe](https://www.keypedia.com/people/beatrix-d-hippe/4a5a5258-3099-46cd-9e56-2dce60668ac5)

Company: https://www.keypedia.com/companies/padagis-us-llc/d356236a-0058-4d8b-86ad-56011f641c96

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d