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The FDA hit Grind Guard Technologies with a Form 483 for failing to review all complaints, faulty procedures for suppliers and quality audit deficiencies. Read More
The agency observed that 4 of 12 complaints reviewed involved a device manufactured by the company getting stuck to the customer’s teeth and in some cases required professional dental care. Read More
There were numerous discrepancies between documented X-ray peak energy values in the collimator leakage test procedure and the production log. Read More
The budget request includes $100 million to advance the use of real-world experience to develop clinical data to expedite medical product development. Read More