US FDA criticizes Indian drug firm USV for problems at multiple sites

The US regulator said USV’s “oversight and control over the manufacture of drugs is inadequate​” in a warning letter published today, citing problems with testing procedures observed during an inspection at its plant in Dabhel, Daman in 2016.

The agency also referenced similar problems uncovered at a facility in Govandi, Mumbai in 2014​.

The Food and Drug Administration (FDA) wrote that: “These repeated problems at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate.​

“You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements​.”

Multi-site warning letters ​

The letter to USV is similar to a warning​ sent to fellow Indian drug manufacturer Wockhardt this month in which the US agency detailed problems observed at seven of the firm’s facilities in recent years. 

The FDA told us: "The USV warning letter is for a single facility, as is the Wockhardt warning letter. They each reference recently issued WL(s) to sister facilities. Though we have issued WLs to multiple sites.​

The agency added that: "These are considered corporate warning letters. The scope of a corporate warning letter extends to organization-wide practices, rather than problems limited to an organizational​."

USV makes active pharmaceutical ingredients (APIs), small molecule drugs and biosimilar products. On a section about its API business on its website, the firm claims to have had a “presence in US and EU markets​” for two decades

It also says it supplies finished drugs to multiple markets, including the US and Europe.

The firm did not respond to a request for comment.