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A New Jersey-based drug compounder and two of its top corporate officials have been indicted on fraud charges for repackaging and distributing unsterile drugs to several states. Read More
The FDA’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More
Health Canada has launched an online public database of information relating to drug company inspections, including which firms have a good history of meeting safety and quality standards and which do not. Read More
The FDA and Department of Justice are pursuing prosecutions of several international drugmakers, investigators and clinical trials coordinators for conduct and data integrity violations, underscoring the agency’s increasing tendency to treat quality violations as fraud. Read More
High-ranking U.S. Food and Drug Administration officials visiting India have laid out a new approach to facility inspections for Indian manufacturers that would reward firms if their quality management system exceeds minimum compliance requirements. Read More
The FDA has warned a French drugmaker for data integrity issues related to the production of active pharmaceutical ingredients at its Thailand manufacturing plant. Read More
UK inspectors cited 19 companies for critical pharmacovigilance weaknesses in the fiscal year ending March 31, 2014, roughly even with the 18 citations in the previous year. Read More
Hospira will have to delay the opening of its new Visakhapatnam, India, plant because of persistent problems turned up during FDA inspections of the facility. Read More
A slew of observations related to cleanliness and sterility at Patheon Manufacturing Services’ Greenville, N.C., facility have resulted in a Form 483. Read More