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

An FDA inspection conducted at Vetter Pharma-Fertigung GmbH & Co. KG in Ravensburg, Germany, from August 22 to August 26, 2022, resulted in the issuance of a Form FDA 483, detailing observations related to the firm’s drug product manufacturing processes. The inspection identified three primary areas of concern. Firstly, written procedures for production and process control were found to be deficient. Specifically, inspectors observed instances where a Restricted Access Barrier System (RABS) was introduced into critical airflow during fill line setup without proper sanitization. Additionally, investigations into non-integral HEPA filters in manufacturing areas were deemed inadequate, lacking comprehensive product quality impact assessments, including reviews of product complaints and reserve samples. Secondly, an equipment system supporting drug product manufacture was not adequately maintained, with a mechanical box cover on a fill line observed as not sealed as designed. Lastly, the company failed to adhere to its own standard operating procedure for Good Documentation Practices, evidenced by improper corrections (write-overs) in a storage logbook. These observations highlight concerns regarding the control and assurance of drug product identity, strength, quality, and purity. Vetter Pharma is expected to thoroughly address these findings and implement comprehensive corrective actions to ensure compliance with regulatory expectations.