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The number of devicemakers receiving FDA warning letters following quality system inspections decreased 12 percent in 2013, compared with 2012 — the first decline since 2009. Read More
The FDA is asking a federal court to permanently enjoin Pharmaceutical Innovations from manufacturing, selling and distributing ultrasound devices and gels. Read More
International medical device regulators are trying to entice more companies to participate in a single-audit pilot program, promising they will receive no warning letters unless the issues pose an immediate threat to public health. Read More
The FDA has unveiled a broad plan that will change the way it inspects devicemakers, handles recalls, issues and reviews enforcement decisions and screens imports, with companies likely to start feeling the impact by the end of 2015. Read More
Using QSIT for internal audits could put devicemakers in a much stronger position when FDA investigators coming knocking on the door, compliance experts agree. Read More
Cook Medical is under FDA pressure to fix sweeping quality problems at its Indiana facility with the way it addressed more than 735,000 manufacturing noncomformances over a two-year period. Read More
As EU notified bodies begin conducting the unannounced audits required by the European Commission, devicemakers need to make sure they have at least two employees who are prepared to handle an audit. Read More
Medtronic Ireland failed to submit MDR reports within 30 days of becoming aware of an event, including two that involved the death of a patient, according to a May 15 Form 483, recently released. Read More
Terumo BCT has received a Form 483 citing manufacturing problems with incoming product acceptance and environmental controls on its blood collection systems. Read More