FDA Inspection 1319262 — Babyation Inc.
The FDA completed an inspection of Babyation Inc. on May 28, 2026 in Saint Louis, MO. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- May 28, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23247 | ISO 13485:2016 Clause 8.3.4 | Reworked product not verified |