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

Source: https://www.keypedia.com/records/483/babyation-inc/2a7fc53a-d2fe-4ba6-a3f8-312939d2c7bd

> 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: Kansas City District Office
- Summary: An FDA inspection of Babyation Inc., a manufacturer of Class II medical devices in Saint Louis, MO, revealed a significant issue regarding the verification of reworked products. The firm failed to adequately ensure that reworked medical device components met applicable acceptance criteria and regulatory requirements, specifically concerning cGMP compliance and comprehensive testing. This lapse could impact the safety and efficacy of distributed devices.

## Related Documents

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

## 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/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79