FDA 483 - Biodominium Diagnostics - August 12, 2022

Prime Lab USA Corp. received a Form 483 citing numerous deficiencies in its quality system, primarily related to inadequate validation for its ELISA Test Kits and insufficient environmental controls for product storage and shipping. The firm also failed to adequately establish and implement procedures for complaint handling, corrective and preventive actions, change control, supplier control, device master records, quality audits, acceptance activities, MDR reporting, and management reviews.