# FDA 483 - Padagis US LLC - April 08, 2026

Source: https://www.keypedia.com/records/483/padagis-us-llc/f7be08b3-bfe6-4fe4-9988-a46231266aed

> FDA 483 for Padagis US LLC on April 08, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Padagis US LLC
- Inspection Date: 2026-04-08
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Padagis US LLC identified seven significant observations related to manufacturing practices for drug products, dietary supplements, and acidified foods. The firm failed to establish adequate laboratory controls, stability program procedures, and production process controls for drug products. Additionally, issues included inadequate sanitation, incomplete product specifications for dietary supplements, a deficient hazard analysis for human food, and the absence of a scheduled process for acidified foods.

## Related Documents

- [483 - 2024-09-06](https://www.keypedia.com/records/483/padagis-us-llc/f48ce613-ab89-48a6-b71d-008539b67ebf) — date: September 6, 2024
- [EIR - 2017-07-07](https://www.keypedia.com/records/eir/padagis-us-llc/74b16a8d-5cf9-40d1-8ad9-b78b50f5c290) — date: July 7, 2017

## Related Officers

- [Beatrix D. Hippe](https://www.keypedia.com/people/beatrix-d-hippe/4a5a5258-3099-46cd-9e56-2dce60668ac5)
- [Elizabeth R. Bloom](https://www.keypedia.com/people/elizabeth-r-bloom/51c7ec4e-97bb-4543-adc3-cf02d335f159)
- [Courtney R. Ingalsbe](https://www.keypedia.com/people/courtney-r-ingalsbe/534b281d-a2bf-473c-b17a-dc1ff42147df)

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