FDA Inspection
Iotron Technologies IncIotron Technologies Inc – FDA Inspection, May 23, 2013
Record Details
This FDA Inspection record concerns Iotron Technologies Inc, with an inspection on May 23, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Iotron Technologies Inc
- Inspection Date
- May 23, 2013
- Product Type
- Devices
View Company Profile
ID · 917e2cf7-ab04-45f1-8081-04bb3964f86d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 841553
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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.