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Unimicro Medical Systems-Shenzhen Co., Ltd. manufactured Veress Pneumoperitoneum Needles in violation of FDA's Quality System Regulation (21 CFR Part 820), with the primary deficiency being failure to establish and maintain adequate procedures for controlling nonconforming products. During an FDA inspection in September 2021, investigators found that the company could not account for the disposition of multiple packages of heat-sealed nonconforming products, which were marked for "return to warehouse" with no documented final disposition, leaving the location and handling of these devices unknown. This adulteration finding indicated the company's manufacturing methods, facilities, and controls did not meet current good manufacturing practice requirements.