FDA Inspection
Ecotron Co. Ltd.Ecotron Co. Ltd. – FDA Inspection, Mar 31, 2017
Record Details
This FDA Inspection record concerns Ecotron Co. Ltd., with an inspection on March 31, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- Amy M. Cramer (Issuing Officer)
View Company Profile
ID · d8e23670-5e9c-4ad8-b562-2f0d42c1e8d6
Inspection Facts
- Inspection number
- 1007705
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.50(b)Supplier notification of changes
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.