FDA Inspection
Dental Engineering Laboratories, LLCDental Engineering Laboratories, LLC – FDA Inspection, May 21, 2019
Record Details
This FDA Inspection record concerns Dental Engineering Laboratories, LLC, with an inspection on May 21, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ec7dfbb1-5d5a-4e78-b797-2704757cede0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1090504
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(j)Design history file
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