FDA Inspection
Wasatch Product Development, LLCWasatch Product Development, LLC – FDA Inspection, Dec 11, 2025
Record Details
This FDA Inspection record concerns Wasatch Product Development, LLC, with an inspection on December 11, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6a45433c-c122-4b08-8f3f-c76b59e0fdb7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1295192
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Wasatch Product Development, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2026 | Not classified | Denver District Office | Drug Quality Assurance |
| September 12, 2024 | Not classified | Denver District Office | |
| July 26, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 9, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| March 4, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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