Babyation Inc.May 28, 2026

FDA 483 - Babyation Inc. - May 28, 2026

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Record Details

Babyation Inc. in Saint Louis, MO, was cited for failing to adequately verify reworked Class II medical devices. The inspection revealed that reworked products, manufactured by a contract firm, lacked proper documentation for cGMP compliance and comprehensive testing against customer acceptance criteria. A significant portion of the unverified reworked inventory remains available for use.

Company: Babyation Inc.
Inspection Date: May 28, 2026
Product Type: Device
Office: Division of Human and Animal Food Operations - West II
Person: Edward E. Lockwood

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ID · 48a042de-7758-4991-8f1f-53b8314000cc