FDA Inspection
Accord Media, LLCAccord Media, LLC – FDA Inspection, Jun 26, 2017
Record Details
This FDA Inspection record concerns Accord Media, LLC, with an inspection on June 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Andrew J. Garufi (Issuing Officer)
- Ashley Defilippis (Issuing Officer)
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ID · 5967d455-bc41-43af-ac97-272d224a0ba6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1015862
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.120(e)Control number {see also 820.65, 820.184(f)}
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of Accord Media, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2019 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 2, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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