The Warning Letter responded to evaluations made in June and July 2015, when the site was owned by Indian drug maker Sun Pharma.
Contract development and manufacturing organization Frontida acquired the Pennsylvanian site and an Illinois-based site from Sun Pharma in June, 2016, and received the FDA Warning Letter two months later.
FDA issued the Warning Letter in response to breached GMP regulations, including the release of 27 lots of clonidine HCI tablets containing potentially contaminated active pharmaceutical ingredients (APIs).
Frontida COO Ron Connolly told In-PharmaTechnologist Sun Pharma had helped Frontida address the problems identified by the FDA.
“Immediately upon the acquisition, Frontida established a new quality leadership team for the operations, reorganized and added scientists to the existing laboratory teams to improve workflows, and implemented corrective and preventative actions that included investing in a new electronic quality management system,” he told us.
Frontida also announced that it plans to hire an additional 40-50 personnel in the next 6 months to support planned new prescription and OTC drugs for the US and international markets.
“Frontida is also partnering with pharmaceutical companies to launch 20 products that were previously approved at the facilities. Frontida’s partners will launch seven products in the US by the end of 2017,” said Connolly.
Frontida supplies prescription and OTC products, Highly Potent Active Ingredients (HPAI), fixed-dose combination products and DEA schedules II-V products.