FDA Inspection
Arciplex LlcArciplex Llc – FDA Inspection, Jun 28, 2016
Record Details
This FDA Inspection record concerns Arciplex Llc, with an inspection on June 28, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Arciplex Llc
- Inspection Date
- June 28, 2016
- Product Type
- Devices
View Company Profile
ID · f4394110-927c-452c-b490-9392c0f950ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 975424
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.184DHR content
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