Sun Pharma’s Mohali plant on FDA radar
US FDA started a three-day surprise inspection at Sun Pharmaceutical’s Mohali plant in Punjab on Monday
New Delhi: Two days after the US Food and Drug Administration (FDA) issued six observations related to deficient procedures at Sun Pharmaceutical Industries Ltd’s Halol manufacturing facility, the regulator also turned up the heat on the drug company’s Mohali plant in Punjab by starting a three-day surprise inspection at the plant on Monday.
The US drug regulator had found seven breaches of manufacturing standards at the Mohali plant during an inspection between 7 and 16 November 2016 and had issued Form 483, citing four deviations in the laboratory system, two in the quality system and one in production. Form 483 is issued to a company’s management at the conclusion of an inspection, when investigators observe any conditions that may violate the Food Drug and Cosmetic Act and related Acts.
The Mohali facility, which belonged to Ranbaxy Laboratories Ltd, had been under an import alert by the FDA in 2013, two years before Sun Pharma completed its $4 billion acquisition of Ranbaxy.
The FDA had lifted the import ban on the Mohali unit sometime ago, but two people aware of the matter said that the regulator conducted a surprise inspection on Monday.
Sun Pharma did not comment on the FDA inspection at Mohali. Shares of Sun Pharma fell 3.72% from its previous close to ₹639.50 on BSE.
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