Sun Pharma faces surprise audit by the USFDA

Sun Pharma's manufacturing facility in Halol (Gujarat) is undergoing a surprise inspection by the US Food and Drug Administration (US FDA). The inspection that started on Monday is still ongoing. The Halol plant was last inspected in September 2012.

USFDA inspectors in two teams are auditing both the injectables as well as oral solids units at the plant, with one team focusing on manufacturing processes and the other closely auditing quality control and assurance departments. Recently, a report said, "We expect higher FDA scrutiny during its next inspection at Sun Pharma's Halol facility given the recall of three products in last six months and import alert at Karkhadi plant."

In May, Sun Pharma's another manufacturing facility in Karkhadi, had received a warning letter from the US FDA after investigators identified violations of current good manufacturing practice and regulations for finished pharmaceuticals. Sun Pharma had also recalled 40,000 bottles of Venlafaxine Hydrochloride extended-release tablets from the US market in July 2014 as the stability results found the product did not meet the drug release dissolution specifications. The company also recalled 200 vials of Gemcitabine in July for lack of sterility assurance and 2,528 bottles of Metformin for packaging problems in March. While all recalls were limited to specific batches, all the three products were manufactured at Halol.