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Western Enterprises/Scott Fetzer Company received an FDA warning letter after averaging its suppliers’ quality ratings with its delivery ratings, resulting in a higher overall rating for some suppliers. Read More
The FDA has warned Ambco Electronics after the devicemaker failed to correct deficiencies noted during a California Department of Public Health inspection and an earlier FDA inspection. Read More
The FDA has cited Zoll Manufacturing for failing to adequately validate its Class III medical Life Vest, noting that “approximately half of all treatments delivered to patients are inappropriate shocks,” according to a recent warning letter. Read More
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