FDA 483 - Winter Innovations, Inc. - December 01, 2023

Winter Innovations, Inc. in Eden Prairie, MN, was inspected from November 29 to December 1, 2023. The inspection revealed one significant observation concerning inadequate procedures for design validation. Specifically, the firm failed to establish sufficient acceptance criteria for the pouch sealing process qualification of its EasyWhip suture-needle product, resulting in distributed units that did not meet specified minimum seal strength values without documented justification.