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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
The European Commission wants drugmakers to use a risk-management approach to qualify and validate manufacturing processes that covers the lifecycle of the product. 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
The FDA warned an Indian manufacturer to immediately stop ignoring poor test results, the second Indian facility last month to get a warning letter for data integrity violations. Read More
Details are starting to emerge on how the FDA’s quality metric collection program will be structured, with drugmakers likely being able to submit metrics data electronically to the agency using a downloadable form. Read More
UK regulators shut down a plant in Cambridgeshire that was producing an unapproved and unlicensed product used against diseases such as HIV and cancer. 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
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
Contract OTC drugmaker Thibiant International allowed unauthorized personnel to access areas of the firm’s buildings and facilities designated as limited access areas, according to an FDA Form 483. Read More