The FDA issued Granules India three observations following a recent pre-approval 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.
