FDA WARNING_LETTER - IsoTis OrthoBiologics, Inc. - October 17, 2025

The FDA issued a Warning Letter to IsoTis OrthoBiologics, Inc. following an inspection from October 6 to October 17, 2025, regarding the manufacture of resorbable calcium salt bone void filler devices. The inspection found that the firm"s devices are adulterated because its manufacturing, packing, storage, or installation methods, facilities, or controls do not conform with the Quality System regulation (21 CFR Part 820). Major violations include a failure to adequately establish procedures for corrective and preventive action, specifically concerning an unaddressed issue of particulate contamination from demineralization equipment, and insufficient verification of corrective measures. The company also failed to revalidate the demineralization process after a significant design change and did not validate its visual inspection method for contaminants. Furthermore, the firm failed to establish an adequate risk analysis, not updating risk management files to reflect new manufacturing-related particulate contamination risks, and conducted a deficient Health Hazard Evaluation despite acknowledging potential contamination of over 500,000 devices since 2008. IsoTis OrthoBiologics, Inc. must promptly address these violations, notifying the FDA within fifteen business days with specific corrective and preventive steps, a timetable, and supporting documentation. All corrective actions must adhere to the new Quality Management System Regulation (QMSR), effective February 2, 2026, to avoid further regulatory action.