FDA Inspection
DIGIMED CO., LTDDIGIMED CO., LTD – FDA Inspection, Jun 14, 2011
Record Details
This FDA Inspection record concerns DIGIMED CO., LTD, with an inspection on June 14, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DIGIMED CO., LTD
- Inspection Date
- June 14, 2011
- Product Type
- Devices
View Company Profile
ID · 56436cd8-7d4e-422e-9b26-8a44453f67b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 732010
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
5- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(c)Documentation
- 21 CFR 1020.30(j)Mandatory warning on control panel
- 21 CFR 1002.13Failure to submit
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.