FDA 483 - Sypharma Pty Ltd - November 22, 2022

During an FDA inspection from November 14-22, 2022, Sypharma Pty Ltd., a sterile animal drug manufacturer in Victoria, Australia, received a Form FDA 483 citing multiple observations regarding its compliance with manufacturing standards for U.S. products. Key issues spanned several operational areas. In facility and equipment management, the firm failed to conduct required integrity tests on a critical sterilizing filter for several years, a repeat observation from a 2016 inspection. Additionally, physical gaps in warehouse exterior doors were observed, posing a risk of pest intrusion, with dead insects found in areas storing materials and finished products. The company also used non-validated wooden pallets without verifying their treatment status.

The production system exhibited significant shortcomings, including the absence of written procedures for visual inspection of products, a lack of established defect criteria (critical, major, minor), and no annual requalification process for visual inspection operators. Furthermore, Sypharma did not adhere to its internal schedule for auditing critical raw material and packaging suppliers. Laboratory system observations included the failure to visually inspect retain samples for deterioration and the use of unqualified handheld calculators for analytical result calculations.

These findings indicate a need for comprehensive corrective actions to align Sypharma's operations with the expected regulatory framework for animal drug manufacturing. The company is expected to provide a detailed response to the FDA outlining its plans to address these observations and ensure ongoing compliance.