# FDA 483 - Lonza AG (Standort Sterilprodktion Stein) - Unknown Date

Source: https://www.keypedia.com/records/483/lonza-ag-standort-sterilprodktion-stein/44da5856-2fdf-4154-be1f-a39be2123605

> FDA 483 for Lonza AG (Standort Sterilprodktion Stein) on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza AG (Standort Sterilprodktion Stein)
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: Lonza AG in Stein, Switzerland, was inspected by the FDA, resulting in one observation. The inspection found that equipment components used in a drug product filling line were not sterilized prior to use, indicating a potential risk to product quality and patient safety. This suggests a significant lapse in aseptic processing controls.

## Related Officers

- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

Company: https://www.keypedia.com/companies/lonza-ag-standort-sterilprodktion-stein/816bf25d-ef8d-4c10-bd9b-63a7dfde275b

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0