Tesla Biohealing, Inc. – FDA 483, Apr 16, 2026

Tesla Biohealing, Inc. in Milford, DE, was inspected regarding its manufacturing of various Biophotonizer medical devices. The inspection revealed significant deficiencies across its quality system, including inadequate design and development validation, poor complaint handling procedures, unvalidated software, and undocumented risk management processes. Additionally, the firm failed to establish supplier evaluation criteria, properly document corrective actions, and provide correct Unique Device Identifier (UDI) information to the FDA.