US FDA did not find issues with Wockhardt's Chikalthana plant

The US health regulator has suggested continuous voluntary compliance for desired quality culture

Drug maker Wockhardt Ltd today said the US health regulator has not found any issues with respect to data security and control measures at Chikalthana plant in a recent inspection, but suggested continuous voluntary compliance for "desired quality culture".

"The recent inspection at the Aurangabad L1-Chikalthana site was a follow-up inspection by the US FDA as an outcome of completion of good manufacturing practise (GMP) remediation submitted by Wockhardt in October 2014.

"There were no findings with respect to data security and control measures in laboratory and manufacturing," Wockhardt said in a BSE filing.

The company further said: "The agency has indicated a common goal as voluntary compliance which shall be a continual process facilitating the concept of 'right the first time and every time' leading to desired quality culture."

In November 2013, US Food and Drug Administration had imposed restrictions on import of medicines produced at the company's Chikalthana plant at Aurangabad in Maharashtra due to non-compliance of good manufacturing practise.

Elaborating on inspection, Wockhardt said: "The observations on Form FDA 483 are on products manufactured prior to execution implementation of (GMP) remediation program."

"The efforts for data security control has been throughly verified during the inspection and have been appreciated as it is qualified and executed since September 2013," it added.