# FDA 483 - F. Hoffmann-La Roche AG - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/f-hoffmann-la-roche-ag/ea1d5604-e9fe-453a-9201-d1168dfc97a2

> FDA 483 for F. Hoffmann-La Roche AG on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: F. Hoffmann-La Roche AG
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: An FDA inspection of F. Hoffmann-La Roche Ltd.'s drug substance manufacturing facility in Basel, Switzerland, identified an inadequate monitoring frequency for water used in manufacturing. Specifically, the water used directly in the process stream was not sampled frequently enough for bioburden and endotoxin at its points of use. This indicates a potential quality control issue in the manufacturing process.

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Company: https://www.globalkeysolutions.net/companies/f-hoffmann-la-roche-ag/32148dda-fc73-4c59-98ba-f5483a05f328

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