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German health officials called for a ban on imports to the European Union from a plant operated by Dr. Reddy’s Laboratories in India, following inspections finding poor quality controls, dirty equipment, and other shortcomings. Read More
Brazil’s National Surveillance Agency has added Ireland’s standards authority to its list of accredited organizations to perform quality management system audits under the Medical Device Single Audit Program. Read More
The European Medicines Agency is putting off plans for GMP inspections in the U.S. when possible, an EMA spokesperson confirmed, in anticipation of the November launch of a mutual agreement between the EU and U.S. Read More
The FDA finalized its list of 1,003 class II medical devices low-risk enough to be exempt from 510(k) requirements, but stressed that all devices, exempt or otherwise, are subject to current device GMPs, packaging and labeling rules, and regulations on intended use. Read More
Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on inspections, Form 483s and warning letters, says Michael Gaba, a partner in the law firm Polsinelli. Read More
The FDA found substantial sterility problems on a visit to Kansas-based ARJ Infusion Services, makers of in-home intravenous medications for adults and children with rare and chronic conditions. Read More