# FDA 483 - Ricola Ag - February 18, 2022

Source: https://www.keypedia.com/records/483/ricola-ag/c26c2209-0422-451f-857b-4f385c4a0d97

> FDA 483 for Ricola Ag on February 18, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ricola Ag
- Inspection Date: 2022-02-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Ricola Ag, a pharmaceutical manufacturer, was cited for failing to thoroughly review unexplained discrepancies and batch failures during an FDA inspection. Specifically, 32 investigations into metal contamination over two years lacked identified root causes and corrective actions. This indicates a significant lapse in their quality management system.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.keypedia.com/companies/ricola-ag/a15e3080-9c44-443f-9ee2-ad04bbeca28d

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1