FDA Slaps Emcure, Lupin for GMP Violations

March 21, 2016

The FDA has slammed two more Indian drugmakers — Emcure Pharmaceuticals and Lupin —for cGMP violations.

A Jan. 27 to Feb. 4, 2015 inspection found that Emcure failed to establish and follow sufficient written procedures designed to prevent microbiological contamination of products.

The Emcure letter cites violations such as an operator placing a cup on the floor of an ISO 7 area to collect water from a unit. In addition, operators were observed crawling on the floor during routine aseptic filling operation activities.

Lupin has landed in hot water with the FDA after inspectors at the company’s Goa plant observed nine apparent GMP violations.

The inspection led agency inspectors to cite the company for failings such as “inadequacy and adherence” to standard operating procedures, according to the company.

Lupin said it is “in the midst of putting together a response to address” the agency’s observations.