FDA 483 - Baxter Healthcare Pty Ltd - July 05, 2022

Baxter Healthcare Pty Ltd, a manufacturer of sterile human drugs in Old Toongabbie, Australia, was cited for failing to follow procedures designed to prevent microbiological contamination. The inspection revealed significant issues with documentation regarding HEPA filter repairs, including conflicting records and a lack of investigation into these discrepancies. These deficiencies impact sterile drug products, including specific injections, intended for the US market.