FDA 483 - Beyond International Inc - February 28, 2024

An FDA inspection of Beyond International Inc, a medical device manufacturer in Sugar Land, TX, revealed significant deficiencies across its quality system. Observations included a lack of proper certification for dental lasers, failure to submit required annual reports, and missing Unique Device Identifiers on several Class I medical devices. The firm also demonstrated inadequate procedures for Medical Device Reporting, corrective and preventive actions, control of nonconforming products, and servicing activities.