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C.R. Bard received an FDA Form 483 for storage area control and other manufacturing issues. The company had not performed temperature mapping studies to find “cold spots, hot spots, dead spots.” Read More
Beginning this month, all devicemakers holding CE certificates for devices classified as Class IIa and above should be prepared for unannounced quality system visits by notified body inspectors. Read More
The FDA has closed out a warning letter issued to online genetics testing firm 23andMe, following the company’s agreement to take its health-related tests off the market. Read More