# FDA 483 - Similasan AG - April 27, 2026

Source: https://www.keypedia.com/records/483/similasan-ag/3fe2d162-988a-4466-a202-3ece7b76c545

> FDA 483 for Similasan AG on April 27, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Similasan AG
- Inspection Date: 2026-04-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Similasan AG, a homeopathic pharmaceutical manufacturer in Ittigen, Switzerland, was inspected by the FDA, revealing significant deficiencies. The observations primarily concern inadequate quality control for components, insufficient process validation, and poor equipment control and in-process checks. These issues indicate a lack of robust controls to ensure drug product quality and consistency.

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- [483 - 2023-04-04](https://www.keypedia.com/records/483/similasan-ag/28e4dc28-bcbe-4843-afe5-a019433124cc)
- [483 - 2023-04-04](https://www.keypedia.com/records/483/similasan-ag/c751572d-e155-49f0-ab76-2f735d352923)
- [WARNING_LETTER - 2023-04-04](https://www.keypedia.com/records/warning_letter/similasan-ag/1df517b1-665c-4dec-88b7-c8369da44de2)

## Related Officers

- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)
- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.keypedia.com/companies/similasan-ag/c9b97bc2-9876-49bf-9b34-57cf8c5717e8

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8