# FDA 483 - Siegfried Pharma AG - December 13, 2019

Source: https://www.keypedia.com/records/483/siegfried-pharma-ag/167d4267-9147-4ddf-be4b-2898ea972584

> FDA 483 for Siegfried Pharma AG on December 13, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Siegfried Pharma AG
- Inspection Date: 2019-12-13
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Siegfried Pharma AG in Zofingen, Switzerland, was cited for five observations during an FDA inspection. The inspection revealed significant deficiencies in laboratory controls, including inadequate impurity and dissolution testing, as well as issues with equipment design and cleaning. Additionally, the firm failed to conduct appropriate annual product quality reviews.

## Related Documents

- [483 - 2019-12-13](https://www.keypedia.com/records/483/siegfried-pharma-ag/6428650c-7339-4114-bc3e-f5e4bf650bba)

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.keypedia.com/companies/siegfried-pharma-ag/a8b1112e-23c8-4f17-9eb6-0c147beb232a

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3