FDA Inspection
Arc Devices USA IncArc Devices USA Inc – FDA Inspection, Aug 31, 2018
Record Details
This FDA Inspection record concerns Arc Devices USA Inc, with an inspection on August 31, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c05eae90-6216-4995-a340-683c41d3109f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065455
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.160(b)Distribution records
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