FDA 483 - Tesla Biohealing, Inc. - March 23, 2023

An FDA inspection of Tesla Biohealing, Inc. in Milford, DE, a manufacturer of MedBed Generators and BioHealers, revealed significant deficiencies. The firm failed to provide scientific evidence for its devices' broad intended uses, did not properly evaluate suppliers, and used unscientific methods for device testing. Furthermore, the company lacked an adequate organizational structure with quality and regulatory representation and failed to implement essential quality control procedures.