FDA Inspection
Enuresis Solutions, LLCEnuresis Solutions, LLC – FDA Inspection, Mar 26, 2019
Record Details
This FDA Inspection record concerns Enuresis Solutions, LLC, with an inspection on March 26, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 727149fe-32f5-48fa-97f9-16eca3c8df69
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083916
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Enuresis Solutions, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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