FDA 483 - Beyond International Inc - February 28, 2024

During an inspection conducted from February 20-28, 2024, the FDA issued a Form FDA-483 to Beyond International Inc., a medical device manufacturer located in Sugar Land, TX. The inspection revealed several significant observations regarding the firm's compliance with regulatory standards for medical devices.

Key issues identified include the lack of proper certification labels or tags on InPulse Dental Lasers, failing to state compliance with FDA performance standards. The company also failed to submit required initial and subsequent annual reports for these laser products, which have been distributed since September 2022. Additionally, several Class I medical devices, such as Heat Source-Accelerators, Cheek Retractors, and Rubber Dams, lacked Unique Device Identifier (UDI) labeling, despite the exemption having expired.

Procedural deficiencies were also noted. Beyond International Inc.'s Medical Device Reporting (MDR) procedures lacked adequate documentation and recordkeeping for annual report evaluations and ensuring timely access to information. The Corrective and Preventive Action (CAPA) system was found to be inadequately implemented, with numerous instances where preventive actions and verification of effectiveness were not documented. Furthermore, the firm's nonconforming product control procedure was inconsistent, listing "repair" as a disposition on a form without defining it in the official procedure. Finally, there were no established procedures for servicing activities, including verification, statistical analysis of service reports, or automatic consideration of service reports as complaints for MDR purposes.

These observations highlight a need for Beyond International Inc. to implement comprehensive corrective actions to address these quality system deficiencies and ensure full compliance with FDA regulations.