The FDA hit Grind Guard Technologies with a Form 483 for failing to review all complaints, faulty procedures for suppliers and quality audit deficiencies.
After inspecting the company’s Clarkston, Michigan facility in January 2018, the agency found that the firm did not properly deal with all complaints. Specifically, it did not evaluate any of a dozen complaints it received to see if they warranted an investigation after reviewing them. The quality system manager confirmed they had not been investigated, but gave no rationale for the reason why.
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 requiring professional dental care. The company did not issue a CAPA request form to further investigate the issue.
The firm also had no agreement with suppliers and contractors to alert the company about changes in the product or service it received from them. The quality system manager confirmed the firm had not arranged any contracts with any of its suppliers to address relevant quality issues.
It also did not perform any quality audits. The firm confirmed it had never conducted an internal audit and did not have an audit plan in place.