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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
The FDA has warned a Kansas compounder for multiple GMP violations, including poor sterile drug manufacturing practices and using ingredients that aren’t FDA-approved. Read More
High-ranking FDA 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 warned Cadila Pharmaceuticals for cGMP violations that include quality controls, complaint handling and data integrity at its Gujarat, India, active pharmaceutical ingredients manufacturing plant. Read More
Drugmakers can help to facilitate facility inspections — and improve their inspection experience — by engaging in constructive conversations with agency investigators, an FDA official says. Read More
To avoid getting cited for poor laboratory controls when FDA investigators come calling, manufacturers should study the mistakes made by their peers, one expert says. Read More
The FDA slapped warning letters on two more drug outsourcing facilities for sloppy sterile processing, bringing to seven the number of compounders cited for sterile manufacturing deviations in the past six months. Read More