FDA Conducts Surprise Inspection at Sun Pharma

Sep 11, 2014

CNBC

On Monday, two teams of U.S. FDA inspectors reportedly arrived at Sun Pharma's Halol facility in Gujarat India to conduct a surprise audit of the injectibles and oral solids units.

Sources say one team is focusing on manufacturing processes and the other is closely auditing quality control and assurance.

The Halol plant is one of Sun Pharma's 25 manufacturing plants, 11 of which are in India. Three of those plants, including the Halol plant, are in Gujarat.

The FDA's surprise visit should not have come as much of a surprise to Sun Pharma, considering Sun's Karkhadi, Gujarat plant was banned from importing to the U.S. in March and then was given a warning by the FDA in May after failing to take adequate corrective actions. Additionally, Sun Pharma has recently recalled three drugs from the U.S. market, all three of which were manufactured at Halol.

Read the CNBC piece

 

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