FDA 483 - Sandoz GmbH - February 20, 2018

An FDA inspection of Sandoz GmbH, Schaftenau, Austria, conducted from February 14-16 and 19-20, 2018, identified several deficiencies in their drug substance and drug product manufacturing operations. The observations, detailed in an FDA Form 483, require the company's attention to ensure compliance with pharmaceutical manufacturing standards.

Key issues included the lack of adequate process data to support microbial hold times for certain drug products at commercial scale. Furthermore, the inspection revealed insufficient controls for testing machines, specifically regarding access control, password protection, and user account management, which allowed unauthorized alterations to testing programs. Standard operating procedures were found to be inadequate, lacking guidance for handling overdue deviations and permitting unapproved modifications to batch records without proper documentation.

Finally, the firm lacked appropriate material control and internal release procedures for materials used in aseptic processing. Sandoz GmbH is expected to promptly implement comprehensive corrective actions to address these observations and ensure the quality and safety of their pharmaceutical products.