FDA Inspection
EKOM spol. s.r.o.EKOM spol. s.r.o. – FDA Inspection, Mar 21, 2024
Record Details
This FDA Inspection record concerns EKOM spol. s.r.o., with an inspection on March 21, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fd9e3c38-38cc-4063-bcec-94be8a40b1ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1233666
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(b)Remedial action
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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 |
| 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 1319224 - 2026-05-28
- FDA Inspection 1016985 - 2017-05-25
- FDA Inspection 811214 - 2012-10-25
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