FDA Inspection
DNE LLCDNE LLC – FDA Inspection, Apr 6, 2018
Record Details
This FDA Inspection record concerns DNE LLC, with an inspection on April 6, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a886c44c-693e-4887-bcc0-d4358b18a606
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047161
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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