FDA Inspection
Crystal Lake, LLCCrystal Lake, LLC – FDA Inspection, Apr 2, 2026
Record Details
This FDA Inspection record concerns Crystal Lake, LLC, with an inspection on April 2, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bb613ff5-376f-479a-8fa0-1d646ae3e93f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1310986
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- ISO 13485:2016 Clause 7.5.8Corrective action procedures not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Crystal Lake, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2017 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| June 5, 2012 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Crystal Lake, LLC
- FDA Inspection 1025996 - 2017-09-13
- FDA Inspection 784965 - 2012-06-05
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