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.