06.01.03
The Therapeutic Goods Administration (TGA), Symonston, Australia has suspended the license held by Pan Pharmaceuticals Limited, Sydney, Australia to manufacture medicines, for a period of six months, which went into effect on April 28th due to serious concerns regarding the quality and safety of products manufactured by the company. The suspension followed audits of the company’s manufacturing premises, which, according to the TGA, revealed widespread and serious deficiencies and failures in the company’s manufacturing and quality control procedures, including the systematic and deliberate manipulation of quality control test data. The license has been suspended in order to urgently address the safety and quality concerns posed by the multiple manufacturing breaches. Due to the serious and widespread nature of the manufacturing problems identified and following expert advice regarding potential risks, the TGA decided to recall all batches of medicines manufactured by Pan Pharmaceuticals since May 1, 2002, and that are being supplied on the Australian market. So far, 219 products manufactured and supplied in Australia by the company have been identified for immediate recall and have been cancelled from the Australian Register of Therapeutic Goods for quality and safety reasons. The company has also had its approval to supply its range of export products (approximately 1650) cancelled. In addition, a further, larger recall of products manufactured by the company under contract for other sponsors was underway as of late April. According to the TGA, Pan’s suspension could be lifted at any time if the company’s meets the regulatory requirements.