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Lax medical device reporting and CAPA procedures as well as a host of other quality issues were uncovered during a July 31 to Aug. 2 FDA inspection of LED Intellectual Properties’ Irvine, Calif. facility. Read More
Many of the inspection findings were repeat observations, flagging document control procedures, labeling activities, and measuring and test equipment not suitable for the intended purpose. Read More
The firm’s quality director and a lab analyst were “unable to explain what ‘deleted result’ meant and they were unable to provide records or documentation explaining the events,” the 483 said. Read More
The FDA hit three foreign device manufacturers with warning letters, calling the firms out for quality system violations that led to adulterated products. Read More
The FDA cited devicemaker Streck for failing to document certain design elements for its Cyto-Chex blood collection tubes, serving the company a Form 483 after a September inspection of its La Vista, Nebraska facility. Read More