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The FDA issued a warning letter to Jilin Shulan after an inspection of the firm’s Shulan City, Jilin Province facility revealed significant GMP deviations for active pharmaceutical ingredients. Read More
The FDA hit API manufacturer Reine Lifescience with a warning letter for significant GMP violations observed during a November inspection of its facility in Gujurat, India. Read More
Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Read More
As part of its increased focus on drug compounding, the FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility. Read More
The EMA noted a steep decrease in GMP inspections in its annual report for 2017, as well as a hike in inspections for good clinical practices and nearly double the amount of pharmacovigilance inspections than the previous year. Read More
The FDA has cut the amount of time it takes to issue post-inspection classification letters nearly in half over the past three years, one of the agency’s top inspection officials said Friday. Read More
The FDA hit Pfizer subsidiary Pharmacia & Upjohn with a Form 483 for inadequate employee training, poor equipment maintenance practices and inadequate sample inspection procedures. Read More
The FDA hit Optikem with a Form 483 after the agency’s investigator observed unsanitary conditions and problems with records in an inspection of the firm’s Denver facility. Read More
The FDA cited API manufacturer CIL Isotope Separations after an inspection of its Xenia, Ohio facility revealed quality control issues, investigational deficiencies and other violations. Read More
The European Medicines Agency released Q&A guidance on prevention of cross-contamination and setting health-based exposure limits (HBELs) for risk identification during drug manufacturing in shared facilities. Read More
Recent FDA warnings and untitled letters show the agency’s enforcement efforts for advertising and promotion are focused on product risk information and pre-approval promotions for investigational drug products, according to two Ropes and Gray attorneys. Read More