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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
The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More
Ensuring data integrity is a crucial task for drug manufacturers wishing to stay out of trouble with the FDA, a top enforcement official at the agency told an industry conference. Read More
The FDA issued a warning letter to a Texas drug compounding facility after it failed to resolve problems identified during an inspection, including serious deficiencies in sterile drug processing. Read More
ORA and CDER officials provided an update on the agency’s Concept of Operations initiative in a Thursday panel discussion at the FDLI’s Enforcement Litigation and Compliance Conference in Washington D.C., detailing the next steps in implementing the concept. Read More
The FDA’s chief counsel said the agency is examining the legal circumstances where a company’s senior personnel and management could be held not only civilly responsible, but also criminally responsible for the actions of those working under them. Read More