Granules India Limited said that the US Food and Drug Administration (FDA) has carried out an inspection of its pharmaceutical manufacturing facility in Chantilly, Virginia, and has made six observations.
The Indian pharma manufacturing company operates the site through its fully-owned subsidiary — Granules Pharmaceuticals.
The FDA inspection took place on 22 July, said Granules India, which expects to respond to the regulator’s observations within the specified time period.
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