# FDA 483 - Zile Bonbons Ag - July 12, 2023

Source: https://www.globalkeysolutions.net/records/483/zile-bonbons-ag/2e968fe9-4860-494b-87f5-c15cf3d83298

> FDA 483 for Zile Bonbons Ag on July 12, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zile Bonbons Ag
- Inspection Date: 2023-07-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Zile Bonbons Ag, an OTC drug manufacturer in Rupperswil, Switzerland, revealed significant deficiencies in their manufacturing processes. The firm failed to ensure drug product expiration dates were supported by adequate stability data and lacked thorough investigations into out-of-specification results. Additionally, issues were identified with laboratory controls, production procedures, batch records, equipment qualification, cleaning validation, component identification, and change control processes.

## Related Documents

- [483 - 2017-08-31](https://www.globalkeysolutions.net/records/483/zile-bonbons-ag/93a9e732-9277-4a4a-bad2-b2e6d3083868)

## Related Officers

- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.globalkeysolutions.net/companies/zile-bonbons-ag/1135877a-589a-43f1-9ec9-42f9ca1553cd

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