FDA 483 - Roche Diagnostics GmbH - March 10, 2023

An FDA inspection conducted at Roche Diagnostics GmbH, a drug substance manufacturer located in Penzberg, Germany, from March 2-3 and 6-10, 2023, identified significant observations concerning equipment validation and document control. Inspectors noted that freezer units used for storing drug substance bulk were not adequately validated, specifically lacking proper temperature mapping for qualification prior to use. Furthermore, the inspection revealed multiple deficiencies in document control. These included instances of noncontemporary documentation leading to backdating, as well as unauthorized overwriting on controlled documents for corrections. The quality unit's oversight was deemed inadequate, as its periodic floor presence failed to detect these deviations. Critical reagents essential for quality control analysis were not stored and used according to specified procedures, and equipment numbers referenced in controlled documents did not consistently match the equipment actually used. These observations represent potential deviations from regulatory Good Manufacturing Practices, requiring Roche Diagnostics GmbH to develop and implement comprehensive corrective and preventive actions to address these findings and ensure compliance, data integrity, and product quality.