FDA Investigator

Kimberly Lewandowski-Walker

Latest inspection on record: Helmbrechts, Germany, November 2017 · records back to 2008

Medical Devices & Rad HealthBiologics

FDA inspection record · Last updated July 12, 2026

Overview

  • 91 inspections across 85 sites are on record.
  • 262 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2017-11-02.

At a glance

Inspections

91

Sites

85

Observations

262

Career since

Jan 2008

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
RAUMEDIC - MUENCHBERG2 Nov 2017Medical Devices & Rad HealthView 483 →
Zevex Incorporated (dba Moog Medical Medical Devices Group)13 Apr 2017Medical Devices & Rad HealthView 483 →
Oscor Inc.23 Mar 2017Medical Devices & Rad HealthView 483 →
Medtronic Vascular Galway DBA Medtronic Ireland27 Oct 2016Medical Devices & Rad HealthView 483 →
Roche Diagnostics GmbH14 Apr 2016Medical Devices & Rad HealthView 483 →

Sites inspected

RAUMEDIC - MUENCHBERGHelmbrechts, Germany1 insp.
Oscor Inc.Palm Harbor, United States1 insp.
Roche Diagnostics GmbHMannheim, Germany1 insp.

Co-investigators

Investigators who share inspections with this person.

Charles M Spyr3 shared
Martha Sullivan Myrick2 shared

Full investigator report

Get the verbatim findings behind Kimberly Lewandowski-Walker's 262 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