Archive for June 2016
European Regulators Threaten to Pull Certificates for Two Indian Companies
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
Read MoreEU Looks to Harmonize U.S. and EU Rules Covering Approval, Guidelines and GMP
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
Read MoreFDA Targets Five Supplement Makers on Claims, Batch Production Records
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 GMP Report
Read MoreXellia, FDA Modify Consent Decree; Site Can Resume Production by 2017
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 GMP Report
Read MoreFDA Letters Slam Four Compounders Over Sterility, Prescription Issues
Four compounders recently received FDA warning letters that faulted them over sterility concerns and other issues. Source: Drug GMP Report
Read MoreFDA Serves Four Drugmakers With Form 483s on GMP Concerns
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
Read MoreFDA Letter Blasts Infusion Options Over Sterility Concerns at Facility
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: Drug GMP Report
Read MorePolydrug Lands FDA Warning Letter on Post-ban Data Integrity Claims
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
Read MoreFDA Letters Target Foreign API Makers Over Data Falsification and Deficiencies
Four foreign API makers have landed FDA warning letters accusing them of violations ranging from data falsification to finished product deficiencies. Source: Drug GMP Report
Read MoreUnwrapped Cannulas Prompt Warning for Grams
The FDA issued Grams Medical a warning letter for sterilization problems related to its reusable cannula tips. Source: The GMP Letter
Read More