cGMPs

FDA Bans Imports from India's Polydrug Labs

Source: Reuters

Sep 15, 2015

The U.S. FDA has banned imports from Mumbai-based Polydrug Laboratories' Ambernath manufacturing plant, citing GMP concerns.

The FDA import alert comes months after Canada and Europe banned the same site for violations that included data integrity issues and a failure to record customer complaints.

Polydrug Manufactures anti-hypertension and anti-fungal meds, as well as muscle relaxants, exporting to more than 70 countries across Europe, North America and Asia.

Read the Reuters press release