FDA 483 - Roche Diagnostics GmbH

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.