FDA 483 - Transfer Technology, Inc. - April 30, 2025

Transfer Technology, Inc. in Huntington Beach, CA, was inspected by the FDA, resulting in three repeat observations. The inspection revealed deficiencies in corrective and preventive action procedures, statistically invalid sampling plans, and inadequate design change procedures, particularly concerning their Class II Cutaneous Electrodes. These issues indicate a systemic lack of adherence to established quality system requirements.