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CooperVision’s Puerto Rico facility has received an FDA warning letter for inadequate investigations into nonconformities and other GMP issues. Read More
CINCINNATI — CDRH’s Office of Compliance expects to begin work on a public database of device quality information, such as MDR reports, by the end of the year, OC Director Steven Silverman told devicemakers May 7 at the FDA/Xavier University MedCon conference. Read More
Routine quality system surveillance inspections of foreign devicemakers increased by 93 percent in 2012, according to newly released FDA data. Read More
CINCINNATI — Manufacturers of combination products can expect draft guidance on current good manufacturing practices in the next several months, staffers in the FDA’s Office of Combination Products said May 8. Read More
Routine quality system surveillance inspections of foreign devicemakers increased by 93 percent in 2012, according to newly released U.S. Food Drug Administration data. Read More
Routine quality system surveillance inspections of foreign devicemakers increased by 93 percent in 2012, according to newly released FDA data. Overall QS inspections were up 37 percent for the year. Read More