483
Roche Diagnostics GmbHFDA 483 - Roche Diagnostics GmbH
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Record Details
Roche Diagnostics GmbH, a drug substance manufacturer in Penzberg, Germany, was cited for significant deficiencies during an FDA inspection. Observations included inadequate equipment validation, specifically for freezers lacking temperature mapping, and widespread issues with document control. These document control problems encompassed noncontemporary documentation, backdating, overwriting, insufficient GMP oversight, and improper handling of critical reagents.
- Company
- Roche Diagnostics GmbH
- Product Type
- Drugs
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ID · 06ecc49c-2224-462e-b964-933d319f0b17