FDA 483 - You First Services, Inc. - May 21, 2021

YFS Pharma, Inc., a medical device manufacturer in Buffalo, NY, was cited for numerous deficiencies in its quality system during an FDA inspection. The observations highlight a systemic failure to establish and follow adequate procedures for quality audits, management reviews, design controls, corrective and preventive actions, complaint handling, supplier qualification, and document control. Several critical design control issues related to their "Lubricity" product were repeat observations from a previous inspection, indicating persistent non-compliance.