Australian manufacturer fined almost $160,000 for allegedly breaching conditions of its medicines manufacturing licence

The Therapeutic Goods Administration (TGA) has issued 12 infringement notices totalling $159,840 to Contract Manufacturing & Packaging Services Pty Ltd, a manufacturer of listed complementary medicines for allegedly breaching conditions of its manufacturing licence.

A recent TGA inspection of the company’s premises identified unacceptable manufacturing practices. It is alleged that in contravention of conditions of its manufacturing licence, the company retested products without taking the required steps to determine the root cause of failures. Repeating testing, without identifying why the product failed, reduces confidence in the company’s ability to ensure their medicines comply with the specifications approved by the TGA. TGA inspectors identified this as a systemic problem which goes against globally accepted Good Manufacturing Practices (GMP). Manufacturing according to GMP is critical to ensure medicines are of good quality. Consistent quality is fundamental to the safety and effectiveness of medicines. 

Since the alleged breaches, the TGA has worked closely with the company to develop and implement effective preventative measures to address the GMP failures. The infringement notices are in response to past breaches and manufacturing can continue. No disruption to the supply of their products is expected because of this action.

Where serious non-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