The FDA doesn’t go into detail about the GMP (good manufacturing practice) violations cited in the import alert but it does say the alert includes antibiotics made at the facility.
Emcure has seven other Indian manufacturing facilities, mostly producing generic drugs and APIs (active pharmaceutical ingredients), and one manufacturing facility in New Jersey that makes soft-gelatin capsules. Products manufactured at the Indian site listed on the import alert are distributed in the US by New Jersey-based Heritage Pharmaceuticals.
Lew Soars, VP of marketing at Heritage, told us the company was “caught by surprise” with the import alert and is “still trying to assess it.”
Back in February, Heritage announced a voluntary US-wide recall of 10 lots of Colistimethate for injection and three lots of Rifampin manufactured by Emcure due to “FDA observations pertaining to aseptic and GMP practices at the manufacturer's site potentially impacting product sterility.”
That same month, Sagent Pharmaceuticals recalled two lots of a muscle relaxant and pulled manufacturing back in-house after product sterility was called into question by the FDA. In May 2014, another recall of Teva products came as that site’s lab testing was not followed in accordance with GMP requirements.
Emcure isn’t the first Indian manufacturer to wind up on the import alert list. Other Indian manufacturing facilities currently on the list include those from Ranbaxy, Wockhardt, Aarti Drugs, Apotex, Ipca Laboratories and Micro Labs.
The crackdown by the FDA comes as the agency has also issued warning letters to Apotex and Micro Labs over data integrity issues. A recent survey from Ernst & Young revealed that one-third of pharma manufacturers and CMOs (contract manufacturing organizations) have yet to review potential gaps in the assurance of data integrity.