The FDA issued Granules India three observations following a recent preapproval inspection at the Indian drugmaker’s U.S. facility.
FDA officials inspected the Chantilly, Virginia, plant from Jan. 24 to Jan 28, and the visit resulted in “three minor observations,” the company said in a statement. The company didn't disclose the nature of the observations.
The audit is part of the agency’s inspection duties for two of Granules product applications slated to be manufactured at the site. The name or type of products weren’t disclosed.
“We are glad to have completed yet another audit with minor observations that we will respond to within the stipulated time period,” Priyanka Chigurupati, a Granules executive director, said in a statement.
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Granules bought the facility from Valeant in 2014 and pumped in about $15 million to get operations running. Then, in 2017, the Hyderabad, India-based manufacturer said it would spend about $35 million to expand the facility by 50,000 square feet for finished dose manufacturing.