FDA Investigator

Eileen M Malecki

Latest inspection on record: Sunnyvale, United States, May 2022 · records back to 2021

Medical Devices & Rad Health

FDA inspection record · Last updated July 12, 2026

Overview

  • 9 inspections across 9 sites are on record.
  • 50 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2022-05-16.

At a glance

Inspections

9

Sites

9

Observations

50

Career since

Aug 2021

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
iHealth Labs, Inc.16 May 2022Medical Devices & Rad Health
RenovoRx, Inc.4 Apr 2022Medical Devices & Rad HealthView 483 →
OMNIlife Science, Inc.11 Mar 2022Medical Devices & Rad Health
Meddev Corp28 Feb 2022Medical Devices & Rad HealthView 483 →
Vivalnk, Inc.10 Dec 2021Medical Devices & Rad HealthView 483 →

Sites inspected

iHealth Labs, Inc.Sunnyvale, United States1 insp.
RenovoRx, Inc.Los Altos, United States1 insp.
OMNIlife Science, Inc.Milpitas, United States1 insp.
Meddev CorpSunnyvale, United States1 insp.
Vivalnk, Inc.Campbell, United States1 insp.

Co-investigators

Investigators who share inspections with this person.

Mary R Hole1 shared
Elizabeth A Dakan1 shared

Full investigator report

Get the verbatim findings behind Eileen M Malecki's 50 observations

Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.

  • New inspections and Form 483s, mapped to the CFR citation
  • Warning letter outcomes, and the citation patterns they repeat
  • Their co-investigators, so no surprises about who shows up on site