FDA 483 - Forward Science Technologies LLC - June 12, 2025

Forward Science Technologies LLC, a medical device manufacturer in Houston, TX, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately validate manufacturing processes and cleaning procedures for its medical devices, including PerioStōm, BioStōm, and SalivaMax. Additionally, issues were noted in design control, including inadequate design verification, missing acceptance criteria for validation, and unverified design changes, alongside failures in complaint handling and corrective and preventive actions, particularly concerning microbial contamination.