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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
CINCINNATI — With September’s deadline for displaying unique device identifiers on high-risk devices just around the corner, rollout for many manufacturers is well underway. Read More
During an FDA inspection, an employee of Precision Needle Manufacturing placed a bin of needle protectors on the ground and then later stacked the same bin on top of another container with exposed needle protectors, according to a Form 483. Read More
Natus Manufacturing Limited, an Irish devicemaker, received an FDA Form 483 for slips related to acceptance activities and contamination-prevention procedures. Read More
Cook Vascular was handed an FDA warning letter for marketing the Cook Evolution RL and the Shortie RL Bi-directional Dilator Sheath Sets without marketing clearance or approval. Read More
Routine quality system surveillance inspections of foreign devicemakers increased by 93 percent in 2012, according to newly released FDA data. Read More
Lawyers are advising devicemakers preparing conflict mineral reports due to the Securities and Exchange Commission this month to put more effort into describing their compliance with the Organisation for Economic Co-operation and Development’s due diligence guidelines. 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CINCINNATI — Manufacturers of combination products can expect draft guidance on current good manufacturing practices in the next several months, staffers in the FDA’s Office of Combination Products said May 8.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
BALTIMORE — Devicemakers in the process of setting unique device identification codes with the FDA may want to bake in some extra time, agency officials say. Read More