FDA Inspection
EDM3 LLCEDM3 LLC – FDA Inspection, Jun 30, 2017
Record Details
This FDA Inspection record concerns EDM3 LLC, with an inspection on June 30, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f1aff385-8e64-42b8-b84e-6e71d98851bf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016612
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.184DHR content
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of EDM3 LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 12, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 6, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for EDM3 LLC
- FDA Inspection 879443 - 2014-05-12
- FDA Inspection 767068 - 2012-02-06
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