USFDA completes inspection of Lupin facility

Lupin announced that the US Food and Drug Administration (FDA) has completed an inspection of its manufacturing facility in Madideep, Madhya Pradesh. The inspection was a routine Good Manufacturing Practices (GMP) audit. An inspection report (FDA-483) was issued listing 15 inspectional observations rightaway. The FDA has found 15 manufacturing deficiencies at the plant during the course of a two-week inspection which concluded on Wednesday. A complete response to all the observations will be submitted to the FDA expeditiously, Lupin said, adding that it has already addressed eight of the observations made by FDA. The outcome of this inspection does not affect the supply of products manufactured at this facility to markets across the world, or the approvability of pending applications with the FDA, the company said.