FDA Inspection
Babyation Inc.Babyation Inc. – FDA Inspection, May 28, 2026
Record Details
This FDA Inspection record concerns Babyation Inc., with an inspection on May 28, 2026, issued by the Kansas City District Office, covering medical devices & rad health.
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ID · 6502c57f-6a55-4634-92f7-e78f7bf6d8af
Inspection Facts
- Inspection number
- 1319262
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- ISO 13485:2016 Clause 8.3.4Reworked product not verified
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Other FDA inspections of Babyation Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Babyation Inc.
- FDA Inspection 1181421 - 2022-10-13
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