FDA 483 - Babyation Inc. - October 13, 2022

Babyation Inc., a medical device manufacturer in Saint Louis, MO, received a Form FDA 483 with three observations following an inspection. The firm was cited for inadequate risk analysis regarding a new material, a lack of established procedures for reworking nonconforming products, and deficiencies in device history records, specifically the omission of product labels. These findings indicate a need for improvements in their quality system processes.