Cyclotek Queensland fined $93,240 for allegedly breaching conditions of its manufacturing licence

The Therapeutic Goods Administration (TGA) has issued 7 infringement notices totalling $93,240 to Cyclotek Queensland Pty Ltd for allegedly breaching conditions of its manufacturing licence. Cyclotek manufactures radiopharmaceuticals used in Positron Emission Tomography (PET) scans.

A recent Good Manufacturing Practice (GMP) inspection by the TGA of Cyclotek Queensland 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.

These infringement notices are in response to past breaches, and it can continue manufacturing. 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 radiopharmaceuticals or impacts on patient services are expected because of this action.

The TGA is working with Cyclotek Queensland 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 report illegal or questionable practices online to the TGA or contact us at GMPCompliance@health.gov.au.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400