Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-28.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 May 2026 – 28 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Mar 2024 – 21 Mar 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 May 2017 – 25 May 2017 | Medical Devices & Rad Health | Clean | |
| 25 Oct 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
28 May 2026
ISO 13485:2016 Clause 7.1
Records of risk management activities in product realization not maintained
Cited by Matthew M Vernon
28 May 2026
ISO 13485:2016 Clause 7.3.1
Design and development procedures not documented
Cited by Matthew M Vernon
28 May 2026
ISO 13485:2016 Clause 7.4.1
Procedures for purchasing process not documented
Cited by Matthew M Vernon
28 May 2026
ISO 13485:2016 Clause 8.2.6
Monitoring and measurement requirements of product characteristics are not met
Cited by Matthew M Vernon
28 May 2026
ISO 13485:2016 Clause 8.4
Procedures for analysis of data not documented
Cited by Matthew M Vernon
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind EKOM spol. s.r.o.'s 3 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat