A company, acting as the Australian sponsor for a range of medical devices manufactured in China, was hit with a notice from the Australian regulator, the TGA, that their products had been tested and were found to be non-sterile.
The TGA requested a product recall and a resolution to the problem.
The company commissioned PharmOut to perform a third party audit at the supplier's facility, to determine their capabilities and how to resolve the problem.
The audit at the supplier's facility revealed that they were unlikely to pass a TGA audit and did not have the necessary controls in place to ensure product quality.
PharmOut identified and recommended an alternative manufacturer in China, with the appropriate TGA approvals and the capabilities to do the work to the required standards.
PharmOut was able to add a visit to the new supplier during an already planned trip to China. At the supplier's facility, the PharmOut consultant confirmed that all the necessary validation documentation was in place for the sterilisation process, as well as for other processes that were deemed a risk to product quality.