The Therapeutic Goods Administration (TGA) has issued 2 infringement notices totalling $37,560 to Global Medical Solutions Australia Pty Limited, trading as Radpharm Scientific Pty Ltd, for allegedly breaching conditions of its manufacturing licence. Radpharm Scientific manufactures cold kit radiopharmaceuticals and sterile saline vials used in diagnostic imaging.
A recent TGA Good Manufacturing Practice (GMP) inspection of Radpharm Scientific identified unacceptable manufacturing practices that presented a risk of unsafe products being supplied. The infringement notices were issued due to the seriousness of the breaches and for not taking appropriate steps to investigate and address manufacturing failures.
The affected batches are no longer in supply and there have been no reports of adverse events associated with their use. No disruption to the supply of products or impacts on patient services are expected because of this action.
The TGA is working with Radpharm Scientific to develop and implement effective preventative measures to address the GMP failures.
Manufacturers are reminded that serious issues must be investigated to prevent recurrence. Where repeated poor compliance is identified at GMP inspections, the TGA may take regulatory actions to ensure that products made at that site do not represent a potential risk to the public.
If you suspect non-compliance in relation to therapeutic goods, you can
