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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
The FDA issued a Form 483 to an Arizona drug compounder for lax monitoring of areas where sterile drugs are produced and for not establishing procedures to prevent contamination of products. Read More
The FDA slapped Canadian generics maker Apotex with a warning letter for serious lapses in current good manufacturing practices at its Bangalore, India, finished product plant. Read More
The FDA has warned an Oregon compounder for multiple GMP violations, including poor sterile drug manufacturing practices, using ingredients that aren’t FDA-approved and not receiving valid prescriptions for drugs it was producing. Read More
Quality problems at an India contract manufacturer are prompting Sagent Pharmaceuticals to recall its injectable atracurium besylate and shift manufacturing of the drug to its U.S. facility, leading to a likely shortage of the product. Read More