FDA 483 - Transfer Technology, Inc. - April 13, 2021

Transfer Technology, a medical device manufacturer in Huntington Beach, CA, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included failures in design control, inadequate device master and history records, ineffective corrective and preventive actions, and improper sampling plans. The firm also lacked established procedures for labeling activities and failed to document in-process inspections.