Sonoma Pharmaceuticals, Inc.
FDA Regulatory Profile
Sonoma Pharmaceuticals, Inc. has 0 FDA recalls, 3 inspections, 8 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Nov 2, 2016 · NAI
- Latest 510(k)
- Jun 24, 2026
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 8 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 3 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3004554409 | Boulder, CO | 3 | Nov 2, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261023 | Microdacyn Wound Irrigation Solution | Jun 24, 2026 |
| K240510 | Microdacyn Hydrogel | Nov 8, 2024 |
| K233399 | Microdacyn Wound Care Solution | Sep 13, 2024 |
| K173896 | Microcyn Antimicrobial Hydrogel | Apr 2, 2018 |
| K171935 | Alevicyn SG Antimicrobial Gel | Dec 1, 2017 |
| K172622 | Microcyn Antimicrobial Skin and Wound Cleanser | Nov 21, 2017 |
| K172851 | Microcyn Plus Antimicrobial Wound Care Solution | Nov 15, 2017 |
| K171727 | Hydrocleanse Antimicrobial Skin and Wound Care Solution | Jul 26, 2017 |