FDA Inspection
EKOM spol. s.r.o.EKOM spol. s.r.o. – FDA Inspection, May 28, 2026
Record Details
This FDA Inspection record concerns EKOM spol. s.r.o., with an inspection on May 28, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · e5f8c409-be32-45f1-bb82-fbe315c36c38
Inspection Facts
- Inspection number
- 1319224
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 8.2.6Monitoring and measurement requirements of product characteristics are not met
- ISO 13485:2016 Clause 8.4Procedures for analysis of data not documented
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
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Other FDA inspections of EKOM spol. s.r.o.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 25, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for EKOM spol. s.r.o.
- FDA Inspection 1233666 - 2024-03-21
- FDA Inspection 1016985 - 2017-05-25
- FDA Inspection 811214 - 2012-10-25
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