FDA Inspection
Accord Media, LLCAccord Media, LLC – FDA Inspection, May 13, 2019
Record Details
This FDA Inspection record concerns Accord Media, LLC, with an inspection on May 13, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d00a033a-5f8c-4b09-a8ce-dd2e69ba4b49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1090021
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- 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 |
|---|---|---|---|
| June 26, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 2, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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