Eugia Pharma Gets Three 483s Since January, Following Inspections of Plants in India

Three Eugia Pharma plants in India have received Form 483s following inspections conducted in the last two months, all laden with examples of the company failing to follow procedures to prevent microbiological contamination of its drug products, among other lapses.

An FDA inspection of the company’s Eugia Pharma Specialities Limited in Sangareddy, Telangana, conducted Jan. 22 to Feb 2, resulted in a 26-page 483 report reflecting nine observations beginning with examples of how procedures designed to prevent microbiological contamination were not established and followed.

Among the examples are that an operator with unsanitized hands leaned over open vials on a fill line, unsanitized forceps were moved from a Grade B area into a Grade A area to remove broken vials, and an operator had hands, forearms and head in a Grade A area directly over exposed sterile items.

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