FDA 483 - Rolence Ent. Inc. - July 11, 2024

Rolence Ent. Inc., a medical device manufacturer in Chungli, Taoyuan, Taiwan, received ten observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality system, including inadequate procedures for design control, corrective and preventive actions, complaint handling, and medical device reporting. Additional issues were noted with device history records, in-process product control, process controls, software validation, and labeling, including the absence of Unique Device Identifiers on device labels.