483
Babyation Inc.FDA 483 - Babyation Inc. - October 13, 2022
Record Details
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.
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ID · 9cc66036-e8e7-4484-9052-b383d19ad57f