FDA Inspection
ARDO MEDICAL AGARDO MEDICAL AG – FDA Inspection, Aug 6, 2015
Record Details
This FDA Inspection record concerns ARDO MEDICAL AG, with an inspection on August 6, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ARDO MEDICAL AG
- Inspection Date
- August 6, 2015
- Product Type
- Devices
View Company Profile
ID · d0e81737-4d92-4b03-b377-48de0546774f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938811
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.200(d)Service reports
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.