# FDA 483 - Babyation Inc. - October 13, 2022

Source: https://www.globalkeysolutions.net/records/483/babyation-inc/9cc66036-e8e7-4484-9052-b383d19ad57f

> FDA 483 for Babyation Inc. on October 13, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Babyation Inc.
- Inspection Date: 2022-10-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/mary-l-schuckmann/fdbfffff-ef4b-49a2-8ea3-6254a600aaac)

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

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