Atlas

FDA-Inspected Site

Unomedical s.r.o.

4 FDA inspections are on record for Unomedical s.r.o. in Michalovce, Slovakia.

483· Form 483 issued

Michalovce, Slovakia · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2018-10-26.

At a glance

Inspections

4

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Oct 2018 – 26 Oct 2018Medical Devices & Rad Health483View 483 →
26 Jan 2015 – 29 Jan 2015Medical Devices & Rad Health483View 483 →
3 Feb 2014 – 6 Feb 2014Medical Devices & Rad HealthWLOn file
22 Jul 2010Not recorded483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

26 Oct 2018
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by John A Sciacchitano

26 Oct 2018
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by John A Sciacchitano

29 Jan 2015
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Erica M Katherine

29 Jan 2015
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Erica M Katherine

22 Jul 2010
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Frank J Marciniak

Investigators

FDA investigators tied to this site in the record.

John A Sciacchitano1 insp.
Erica M Katherine1 insp.
Roy Baby1 insp.
Frank J Marciniak1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations3x
21 CFR 820.100(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 820.70(c)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Unomedical s.r.o.'s 4 Form 483s

Source PDFs, 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