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Will FDA Inspection Observations Fog Speculated Claris Deal?

 
• By Vikas Dandekar

Claris, the Indian injectables maker, has recently been served five observations by the U.S. FDA related to its manufacturing practices in India. The action coincides with chatter about a deal for the firm’s U.S. businesses which analysts believe may now face obstructions due to the regulatory uncertainty.

MUMBAI – India’s Claris Injectables Ltd. has been served five inspectional observations by the U.S. Food and Drug Administration for its Chacharvadi-based facility near Ahmedabad following an inspection between May 4 and 11.

The four-page report addressed to Claris Chairman Arjun Handa cites issues such as incomplete data in laboratory records derived from...

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