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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
A May 17 to July 12 FDA inspection found that Miami Lakes, Florida-based devicemaker Heartware fell short on repeated quality system observations that were cited in a 2014 warning letter and a 2016 FDA Form 483. Read More