Nearly a year after Sun Pharma began implementing a remediation plan to resolve GMP deficiencies at its Halol, India facility, the FDA continues to fault the company for failing to…

Spanish drugmaker Grifols is accused of defrauding the government of millions of dollars for promoting the use of its antithrombin drug, Thrombate III, in unapproved indications. Source: Drug GMP Report

The FDA issued warning letters to two international drug manufacturers for breaching GMP standards by failing to develop procedures to maintain the appropriate quality controls. Source: Drug GMP Report

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