FDA 483 - Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) - August 26, 2022

The FDA inspected Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany, a drug product manufacturer, from August 22-26, 2022. The inspection, conducted by the Division of Biotechnology Manufacturing, resulted in three observations documented on Form FDA 483.

Observation 1 noted deficiencies in written procedures for production and process control. Specifically, the setup of a Fill Line on August 24, 2022, involved RABS into Grade A airflow and Grade B space assembly without sanitization of the RABS into Grade A space. Additionally, two deviations (759735 and 630260) from March 2022 and March 2020, respectively, concerning non-integral HEPA filters in Grade A/B space and outside RABS in Grade A airflow (Grade B space) for the Fill Line, were initially classified as minor. The product quality impact assessment for these deviations was deemed incomplete, lacking a review of product complaints and reserve samples.

Observation 2 indicated inadequate maintenance of an equipment system supporting drug product manufacture. On August 22, 2022, the Fill Line mechanical box cover in Grade A space was observed not to be sealed as designed.

Observation 3 cited a failure to follow a standard operating procedure (SOP). On August 22, 2022, numerous documentation write-overs were