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The FDA’s lawyers and investigators are considering whether a breach of a duty to act or to correct violations must occur before criminal charges are brought. Read More
The FDA warned sterile drug manufacturer PharmScript for adulterated products and insanitary conditions at its Somerset, New Jersey facility. Read More
The FDA cited a Glenmark Pharmaceuticals facility in Solan, India for failing to investigate discrepancies, inadequate complaint records and improper maintenance of quality data. Read More
The FDA flagged three U.S. facilities for a variety of noncompliances observed by agency investigators during inspections, including issues with labeling, failure to properly handle complaints and reporting of adverse events. Read More
Between 2015 and 2016, the number of GMP inspections conducted by European Economic Area authorities of non-EU sites dropped by nearly 25 percent, but the authorities reported more findings of non-compliance over the same time period. Read More
The FDA pharmaceutical inspector of tomorrow will be more specialized by training and more likely to work abroad, according to a high-ranking agency official. Read More
Danish drug regulators moved to shut down a drug importer and repackager due to its inadequate quality control systems, the Danish Medicines Agency said. Read More