FDA 483 - Techno-Aide Inc - February 27, 2020

Techno-Aide Inc, a medical device manufacturer in Nashville, TN, was inspected from February 24-27, 2020, and received a Form FDA 483 with two observations. The inspection revealed significant deficiencies, including the complete lack of an implemented quality system with defined procedures and the absence of written Medical Device Reporting (MDR) procedures. These findings indicate fundamental failures in regulatory compliance for medical device manufacturing.