# FDA 483 - Paragon Swiss - June 12, 2026

Source: https://www.keypedia.com/records/483/paragon-swiss/d3380787-8bc1-4aa3-b595-c4a0cba7ee6e

> FDA 483 for Paragon Swiss on June 12, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Paragon Swiss
- Inspection Date: 2026-06-12
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Paragon Swiss, an API manufacturer in Santa Clara, CA, revealed significant deficiencies in their quality unit and written procedures. The firm failed to conduct annual product quality reviews for their API and did not establish essential written procedures, including recall and equipment requalification procedures. One of the observations regarding the lack of written procedures was a repeat finding, indicating persistent issues.

## Related Documents

- [483 - 2024-01-12](https://www.keypedia.com/records/483/paragon-swiss/c4723d5d-745d-45a5-ab58-24d5e344388c)

## Related Officers

- [Nathan E. Hellman](https://www.keypedia.com/people/nathan-e-hellman/88dc6c17-72bf-4c2c-a952-a4ebcd742142)
- [Stryker, Regulatory Affairs](https://www.keypedia.com/people/gunneet-kaur/e2823ed9-44f2-4553-8984-895ef8c7eece)

Company: https://www.keypedia.com/companies/paragon-swiss/4731e134-17ce-4216-bf50-d696e3dc3256

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df