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Failure to validate design under defining conditions, poor documentation and failure to evaluate complaints were a few of the deficiencies observed during an FDA inspection of surgical lighting manufacturer Sunnex’s Charlotte, North Carolina facility. Read More
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