Medtronic Australasia ordered to pay largest ever penalty for unlawful supply of therapeutic goods.
The medical tech manufacturer was hit with a $22 million fine today by the Federal Court of Australia for unlawfully supplying 16,267 units of the Infuse Bone Graft Kit between 1 September 2015 and 31 January 2020, according to a statement from the Therapeutic Goods Association (TGA) this afternoon.
It is the largest ever penalty received for contraventions of the Therapeutic Goods Act (1989).
“This significant penalty serves as a reminder to sponsors and others in the therapeutic goods industry to take their obligations seriously,” said Professor Anthony Lawler, Deputy Secretary of the Department of Health and Aged Care and head of the TGA.
“Medicines and medical devices supplied to Australians must be assessed by the TGA for safety, efficacy, and performance in the exact way they will be supplied to patients. This protects Australians by ensuring they have access to the safest products available.”
More details in Pharmacy Daily tomorrow.
