FDA 483 - Sypharma Pty Ltd

Sypharma Pty Ltd., a sterile animal drug manufacturer in Dandenong, Australia, was inspected by the FDA, revealing significant deficiencies. The inspection cited repeat failures in equipment maintenance, inadequate visual inspection procedures, and insufficient supplier auditing. Other issues included a lack of retain sample inspection, unqualified laboratory equipment, and poor warehouse sanitation and material handling practices.