The FDA has slapped Polydrug Laboratories’ Mumbai facility with a warning letter for alleged GMP deviations seven months after it received a ban on U.S. imports. Source: Drug GMP Report

The FDA has handed Infusion Options a warning letter for a slew of GMP deficiencies in compounding sterile products and failing to meet 503B conditions for outsourced compounding operations. Source:…

The FDA has issued Form 483s to four drugmakers in the past month over a variety of GMP lapses at their facilities. Source: Drug GMP Report

Four compounders recently received FDA warning letters that faulted them over sterility concerns and other issues. Source: Drug GMP Report

Xellia Pharmaceuticals and the FDA have agreed on a modified consent decree so Xellia can resume manufacturing at the Bedford, Ohio, site it purchased from Ben Venue Laboratories. Source: Drug…

The FDA has zeroed in on five dietary supplement makers in recent weeks, complaining of a laundry list of issues that range from promotional claims to GMP problems. Source: Drug…

The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Source: Drug GMP Report

Two Indian drugmakers risk losing their EU marketing certificates this month after regulators in France and Croatia turned up a multitude of GMP violations. Source: Drug GMP Report