Granules India Hit With Six FDA Observations at Gagillapur Site

The US Food and Drug Administration issues six observations, or potential violations, during an inspection of Granules India’s plant in southern India.

• Inspection of manufacturing practices took place from Aug. 26 to Sept. 6, the pharmaceutical company said in a filing Saturday
• FDA observations are conditions or practices that indicate a product may be in violation of the regulator’s requirements
• Granules is committed to “addressing the observations promptly and will submit its response to the US FDA within the stipulated timeframe,” the Hyderabad-based company said

To contact the reporter on this story:
Chiranjivi Chakraborty in Mumbai at cchakrabort9@bloomberg.net

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