FDA Inspection 1335970 — Maymom LLC
The FDA completed an inspection of Maymom LLC on Sep 16, 2026 in Durham, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 16, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Durham, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 23135 | ISO 13485:2016 Clause 7.3.9 | Records of design and development changes and their reviews not maintained |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |