Overview
- 21 inspections across 19 sites are on record.
- 61 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2018-03-27.
At a glance
Inspections
21
Sites
19
Observations
61
Career since
Sep 2016
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| BiB Production & Packaging B.V. | 27 Mar 2018 | Human Drugs | On file |
| Bayer Bitterfeld GmbH | 23 Mar 2018 | Human Drugs | On file |
| Takeda GmbH, Plant Oranienburg | 16 Mar 2018 | Human Drugs | On file |
| Patheon Pharmaceuticals Inc. | 14 Feb 2018 | Human Drugs | View 483 → |
| Teva Womens Health, LLC | 26 Jan 2018 | Human Drugs | View 483 → |
Sites inspected
BiB Production & Packaging B.V.Roermond, Netherlands1 insp.
Bayer Bitterfeld GmbHBitterfeld-Wolfen, Germany1 insp.
Takeda GmbH, Plant OranienburgOranienburg, Germany1 insp.
Patheon Pharmaceuticals Inc.Cincinnati, United States1 insp.
Teva Womens Health, LLCCincinnati, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Nicholas L Paulin4 shared
Lindsey M Schwierjohann4 shared
Michael P Sheehan3 shared
Mary B Sheets2 shared
Matthew B Casale1 shared
Andrew M Kupper1 shared
Andrew J Barrowcliff1 shared
Heather A Mccauley1 shared
Emily J Orban1 shared
James G Marsh1 shared
Full investigator report
Get the verbatim findings behind Kenneth E Felkley's 61 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