PediaLift LLC – FDA 483, Jan 12, 2018

An FDA inspection of PediaLift LLC, a medical device manufacturer in Mansfield, OH, revealed significant deficiencies across its quality system. The firm failed to establish fundamental procedures for design controls, including design input, output, verification, validation, change, and transfer. Additionally, the inspection found a lack of procedures for quality audits, medical device reporting, device master records, device history records, supplier agreements, supplier evaluations, and document control, indicating a pervasive absence of a robust quality system.