FDA Inspection
Edlen Imaging, LLCEdlen Imaging, LLC – FDA Inspection, Oct 12, 2017
Record Details
This FDA Inspection record concerns Edlen Imaging, LLC, with an inspection on October 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a6761aa6-7c98-41e3-944e-a9b8aa90095a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028486
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 803.17Lack of Written MDR Procedures
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