FDA 483 - Tens Plus Industrial Co. - November 21, 2024

Tens Plus Industrial Co., a medical device manufacturer in Kwun Tong, Hong Kong SAR, was cited for multiple significant quality system deficiencies during an FDA inspection. The firm failed to establish adequate procedures for design control, complaint handling, process control, supplier management, labeling, and medical device reporting. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.