FDA 483 - Pharbil Waltrop Gmbh - June 06, 2025

An FDA inspection of Pharbil Waltrop GmbH in Waltrop, Germany, conducted from June 2-6, 2025, identified two significant observations regarding the company's production and quality systems. Firstly, batch production and control records were found to be incomplete. Specifically, the reconciliation of bulk product used during filling lacked full documentation, with an example noting undocumented rejected samples used in calculations. Secondly, the quality control unit's responsibilities and procedures were not adequately followed. The inspection revealed that the quality unit failed to detect a discrepancy in test data for a technical batch, where the refractive index values differed between the laboratory journal and the certificate of analysis. These observations, documented on an FDA Form 483, indicate a need for the firm to implement corrective actions to ensure accurate record-keeping, complete product traceability, and robust quality control oversight to comply with regulatory standards for manufacturing practices.