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The FDA said that the issues with the device “would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” Read More
The company kept complaints and customer feedback in a bound notebook that displayed part of its complaint regulation in a piece of paper taped to the front. Read More
In addition, written procedures for medical device reporting and CAPA handling were not established, and the firm was written up again for lacking complaint handling procedures Read More
The firm lacked established design control procedures for validations, transfers, changes, and didn’t have design history files for each type of device. Read More
An FDAnews analysis of the FDA’s Form 483 inspection reports for fiscal year 2019 shows devicemakers continue to be tripped up at the same old hurdles. Read More
Failure to establish procedures for design changes and for acceptance of incoming product, were among the quality management lapses uncovered during a May 13-16 FDA inspection of Vasamed’s Eden Prairie, Minnesota plant. Read More
Management at Hospital Therapy Products failed to establish a quality plan, quality audits, or procedures for management reviews, a May 7-14 inspection of the firm’s Wood Dale, Illinois inspection revealed. Read More