FDA Inspection
Accord Media, LLCAccord Media, LLC – FDA Inspection, Sep 2, 2016
Record Details
This FDA Inspection record concerns Accord Media, LLC, with an inspection on September 2, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Accord Media, LLC
- Inspection Date
- September 2, 2016
- Product Type
- Devices
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ID · ebb4feb1-4a91-47a5-8090-c5746a2adac6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986213
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.120(e)Control number {see also 820.65, 820.184(f)}
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - simulated testing
- 21 CFR 803.17Lack of Written MDR Procedures
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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 |
| June 26, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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