FDA-Inspected Site

Mego Afek AC Ltd.

2 FDA inspections are on record for Mego Afek AC Ltd. in Afek, Israel.

483· Form 483 issued

Afek, Israel · Last updated July 11, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2020-02-06.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Feb 2020 – 6 Feb 2020Medical Devices & Rad Health483View 483 →
5 May 2011Not recorded483View 483 →

Observations on record

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

6 Feb 2020
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by Vicky L Cruz

5 May 2011
21 CFR 820.30(g)

Design validation - user needs and intended uses

Cited by Stephen D Eich

5 May 2011
21 CFR 820.90(a)

Nonconforming product control

Cited by Stephen D Eich

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.80(d)Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Mego Afek AC Ltd.'s 2 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