# FDA 483 - Babyation Inc. - May 28, 2026

Source: https://www.keypedia.com/records/483/babyation-inc/48a042de-7758-4991-8f1f-53b8314000cc

> FDA 483 for Babyation Inc. on May 28, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Babyation Inc.
- Inspection Date: 2026-05-28
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.

## Related Documents

- [483 - 2022-10-13](https://www.keypedia.com/records/483/babyation-inc/9cc66036-e8e7-4484-9052-b383d19ad57f)

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/babyation-inc/d142e11e-6aa8-46f3-8ab3-e070242a3f0f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8