FDA Inspection
Ion Genius, Inc.Ion Genius, Inc. – FDA Inspection, Aug 1, 2011
Record Details
This FDA Inspection record concerns Ion Genius, Inc., with an inspection on August 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ion Genius, Inc.
- Inspection Date
- August 1, 2011
- Product Type
- Devices
View Company Profile
ID · 038900e6-2ed0-4554-8f5c-bacbfa4e6b1b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 735260
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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.