FDA 483 - Yates Motloid Co - October 24, 2024

Yates Motloid Co, located in Elmhurst, IL, received a Form 483 with two observations following an FDA inspection. The firm was cited for failing to establish procedures for finished device acceptance and for lacking documentation of final review for its ColdPac Powder and Liquid Kit. Additionally, the inspection revealed a lack of established procedures for controlling storage areas and a failure to document temperature conditions for Coldpac Tooth Acrylic Powder, a product with critical temperature requirements.