FDA 483 - Rechargeable Power Energy North America LLC - July 23, 2021

Rechargeable Power Energy North America LLC, a medical device manufacturer in Las Vegas, NV, was inspected and cited for multiple quality system deficiencies. The firm lacked adequate procedures for device history records, complaint handling, medical device reporting, incoming product acceptance, supplier controls, management reviews, and internal quality audits. These issues indicate a systemic failure to maintain a compliant quality system since the last inspection in 2018.