MTI Precision Products received a Form 483 with 8 observations including inadequate design change procedures, maintenance of complaint files, and other issues.
The FDA inspectors reported during a visit to the firm’s Coatesville, Penn., facility in late August and early September 2016 that procedures for design change were inadequate. Specifically, an engineering change for the Sonic Scaler device was not approved by management or evaluated to determine if it required verification or validation. In addition, a design change for the company’s Low Speed Dental Motor was not properly documented.
MTI also failed to properly maintain complaint files when a screw came off a device and was swallowed by a patient. No evaluation was documented to determine if the complaint was reportable under Medical Device Reporting requirements. — Jeff Kinney