FDA Inspection
Maymom LLCMaymom LLC – FDA Inspection, Sep 16, 2026
Record Details
This FDA Inspection record concerns Maymom LLC, with an inspection on September 16, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Maymom LLC
- Inspection Date
- September 16, 2026
- Product Type
- Devices
View Company Profile
ID · 5e34d312-44e4-4912-8652-5cd8d59d07cc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1335970
- Project area
- Compliance: Devices
FDA Citations
3- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- 21 CFR 830Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 7.3.10Records of design and development changes and their reviews not maintained
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Other FDA inspections of Maymom LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Maymom LLC
- FDA Inspection 897981 - 2014-09-16
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