The FDA observed that cleaning and maintenance of equipment did not see any written procedures being followed. The Halol plant had been under FDA scanner since September 2014. The FDA observed that cleaning and maintenance of equipment did not see any written procedures being followed. “The USFDA conducted a Pre-Approval Inspection of Sun Pharma’s Halol facility from 27 August to 31 August. These tablets were manufactured at its Halol plant.

Source: Mint September 07, 2018 16:07 UTC