FDA Inspection
EKOM spol. s.r.o.EKOM spol. s.r.o. – FDA Inspection, Oct 25, 2012
Record Details
This FDA Inspection record concerns EKOM spol. s.r.o., with an inspection on October 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EKOM spol. s.r.o.
- Inspection Date
- October 25, 2012
- Product Type
- Devices
View Company Profile
ID · f2f611df-24e4-413a-a068-f976bd802cf2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811214
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.198(a)General
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of EKOM spol. s.r.o.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 28, 2026 | Not classified | Office of Inspections and Investigations | Postmarket Assurance: Devices |
| March 21, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for EKOM spol. s.r.o.
- FDA Inspection 1319224 - 2026-05-28
- FDA Inspection 1233666 - 2024-03-21
- FDA Inspection 1016985 - 2017-05-25
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.