Biofilm, Inc. – FDA 483, May 19, 2026

Biofilm, Inc., a manufacturer of Class II personal lubricant medical devices in Vista, CA, was cited for failing to submit Medical Device Reports (MDRs) within 30 days for numerous adverse events. The firm's internal records and consumer complaints indicated potential serious injuries, including UTIs, bacterial vaginosis, yeast infections, and blistering, which were not proactively reported to the FDA. This represents a significant failure in post-market surveillance and regulatory compliance.