FDA 483 - You First Services, Inc. - December 18, 2023

You First Services, Inc., a medical device manufacturer in Buffalo, NY, received a Form FDA-483 with five observations following an inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate corrective and preventive action procedures, insufficient complaint handling, and non-compliance with Unique Device Identification (UDI) requirements for labeling and database submission. Additionally, the firm failed to adequately document personnel training for critical manufacturing processes.