# FDA 483 - Lonza AG - December 15, 2017

Source: https://www.globalkeysolutions.net/records/483/lonza-ag/8a04ca07-4b1d-4652-b808-fa39c435dba7

> FDA 483 for Lonza AG on December 15, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lonza AG
- Inspection Date: 2017-12-15
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Lonza AG in Visp, Switzerland, a drug substance manufacturer, revealed one observation. The firm's master production instructions were found to be deficient, specifically lacking defined time and temperature limits for critical processing steps of a starting material. This indicates a potential issue with process control and consistency in manufacturing.

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## Related Officers

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Company: https://www.globalkeysolutions.net/companies/lonza-ag/7084f7e6-ce36-429f-942a-28e759416e70

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd