Sun Pharma’s Mohali Plant Under The Watch Of FDA

Two days after the US Food and Drug Administration (FDA) highlighted six procedural deficiencies at Sun Pharmaceutical Industries Ltd Halol manufacturing site, the regulator intensified its scrutiny by initiating an unannounced three-day inspection at the company's Mohali plant in Punjab on Monday.

The US drug regulator discovered seven instances of manufacturing standards violations at the Mohali plant during an inspection from November 7 to November 16, 2016. They issued Form 483, identifying four discrepancies in the laboratory system, two in the quality system, and one in production. Form 483 is given to a company’s management after an inspection concludes, noting observed conditions that might breach the Food Drug and Cosmetic Act and related Acts.

The Mohali plant, previously owned by Ranbaxy Laboratories Ltd, faced an FDA import alert in 2013. Sun Pharma acquired Ranbaxy two years later for $4 billion. Although the FDA had lifted the import ban on the Mohali facility earlier, two individuals familiar with the situation disclosed that the FDA conducted an unexpected inspection on Monday. Sun Pharma declined to comment on the FDA inspection at Mohali. Following this news, Sun Pharma's shares dropped by 3.72% to ₹ 639.50 on the BSE.