FDA 483 - Unimicro Medical Systems (Shenzhen) Co., Ltd. - September 26, 2021

Unimicro Medical Systems (Shenzhen) Co., Ltd. received a Form FDA 483 with 10 observations following an inspection of their medical device manufacturing facility. The inspection revealed significant deficiencies across various quality system areas, including design control, device master records, process validation, and corrective and preventive actions. These issues indicate a systemic lack of established and maintained procedures for critical manufacturing and quality processes for their Class II sterile Veress Pneumoperitoneum Needles.