FDA Inspection
Vision Diagnostics IncVision Diagnostics Inc – FDA Inspection, May 17, 2017
Record Details
This FDA Inspection record concerns Vision Diagnostics Inc, with an inspection on May 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · e7dbaf27-bc1a-487d-8f73-13e192ba7253
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017001
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate 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.