FDA 483 - Munchkin Inc - October 07, 2021

Munchkin, Inc. in Van Nuys, CA, a medical device manufacturer, was inspected from October 5-7, 2021. The inspection revealed a significant quality system deficiency concerning the firm's design control procedures. Specifically, the design history file for their Class II Munchkin Fun Ice Teether did not adequately demonstrate design development, review results, or design transfer.