US FDA tells Wockhardt to evaluate its plants

FDA has raised concerns over accuracy of tests done by firm at its Waluj and Chikalthana plants

Trouble for Mumbai-based drug maker Wockhardt has increased as the US Food and Drug Administration (FDA) has raised concerns over the reliability and accuracy of tests conducted by the company at its plants in Waluj and Chikalthana in Maharashtra.

In a warning letter on Novemeber 25, FDA asked the company to conduct a global assessment of its plants to ensure its products conformed to FDA requirements for safety, efficacy and quality. FDA has also expressed concern about Wockhardt's inability to implement a robust and sustainable quality system.

Following warning letter that points out Wockhardt’s failure in meeting FDA’s standards, shares of the company slipped four per cent intraday on Wednesday. Wockhardt closed at Rs 403, down 3.82 per cent on the BSE.

CAUGHT IN A WEB

• In May, FDA imposed a ban on the company's Waluj plant after inspectors found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six metres from the entrance to a sterile manufacturing area
• FDA had conducted inspections during July 22- 31 at Waluj and Chikalthana factories. Products from both plants are banned for marketing in the US

“The lack of reliability and accuracy of data generated by your firm’s laboratory is a serious cGMP (current good manufacturing practices) deficiency that raises concerns about the integrity of all data generated by your firm,” the letter said.

The manufacturing violations listed in the latest letter repeat violations revealed in a July warning letter. FDA had conducted inspections during July 22-31 at Waluj and Chikalthana factories. Products from both plants are banned for marketing in the US.

“These repeated observations and citations indicate that your quality unit is not exercising its responsibilities and may not have the appropriate authority or ability to carry out its responsibilities,” said the letter from the director of Office of Manufacturing and Product Quality with FDA.

The Chikalthana plant had generated sales of $283 million (Rs 1,700 crore) in 2012-13. At the Chikalthana plant, Wockhardt makes the generic version of Toprol-XL, a drug for high blood pressure. The company has 26 per cent of the drug’s market share in the US. The plant’s revenue from the UK was £12 million (Rs 120 crore) in FY13. Following an import alert issued by FDA last month, shares of Wockhardt plunged 14 per cent last month.  

In May, FDA imposed a ban on the company’s Waluj plant after inspectors found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six metres from the entrance to a sterile manufacturing area.