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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
Device history records for two of the firm’s Class II medical devices didn’t include or refer to the location of their primary identification labels and labeling for each unit. Read More