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FDA readies India staffing

This article was originally published in The Gold Sheet

Executive Summary

FDA has chosen its staff for positions at its new Mumbai and New Delhi offices in India. An internal memo circulated by FDA and obtained by "The Gold Sheet" shows that its core team will initially include Beverly Corey as acting India country director. Corey has worked at senior positions such as office director for Africa, Asia and the Pacific. Bruce Ross will succeed Corey in a few months. Ross, the acting director at FDA headquarters in Rockville, Md., of the agency's office for Africa, Asia and the Pacific, has served FDA at several locations including Beijing and Bangkok. Helping Ross on technical issues will be Albinus M. D'Sa, who will be designated as the deputy country director, senior technical expert for medicines. D'Sa is known for his expertise on diethylene glycol contamination of glycerin, and has represented FDA at the ICH meeting in Chicago and finalized the guidance on risk management in pharmaceutical manufacturing. Among others selected is Regina Brown, who conducted the recent high-profile inspection of Changzhou SPL in China, which had supplied tainted heparin API to Baxter. FDA also plans to bring in Pankaj Amin, Dipesh Shah and Muralidhar Gavini as consumer safety officers primarily responsible for inspections of manufacturing facilities. FDA has opened the India office as part of its "Beyond Our borders" initiative that plans to establish 14 offices across the world, including three in China

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