Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
ESEKOM spol. s.r.o.Piestany, Slovakia
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 483 report
Get the verbatim text of all 6 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere