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India’s Micro Labs Gets FDA Import Alert For Goa Unit

 
• By Vikas Dandekar

FDA inspections are a central focus for Indian drug industry. The wait continues on the results of the agency’s inspections at Sun Pharma’s Halol site, but another firm, Micro Labs was served an Import Alert for GMP violations at its Goa manufacturing unit.

MUMBAI - India’s Micro Labs Ltd. is the latest to be served an Import Alert by the U.S. Food and Drug Administration. The U.S. regulator posted the alert on Sept. 19 on its Website specifying GMP issues at the Indian drug maker’s Verna, Goa plant. The manufacturing plant was inspected for two or three months and was later issued observations in a Form 483.

Following the observations, that is said to have pointed to deviations in the laboratory results and manufacturing processes, the agency...

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