Overview
- 149 inspections across 128 sites are on record.
- 531 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2026-05-22.
At a glance
Inspections
149
Sites
128
Observations
531
Career since
Nov 2014
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Cambridge Isotope Laboratories, Inc. | 22 May 2026 | Human Drugs | On file |
| Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | 8 Apr 2026 | Human Drugs | On file |
| Sharp Sterile Manufacturing, LLC | 5 Mar 2026 | Human Drugs | On file |
| Anika Therapeutics, Inc. | 22 Jan 2026 | Animal Drugs & Feeds | On file |
| Azurity Pharmaceuticals, Inc. | 12 Dec 2025 | Human Drugs |
Sites inspected
Cambridge Isotope Laboratories, Inc.Tewksbury, United States1 insp.
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLCAndover, United States1 insp.
Sharp Sterile Manufacturing, LLCLee, United States1 insp.
Anika Therapeutics, Inc.Bedford, United States1 insp.
Azurity Pharmaceuticals, Inc.Woburn, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Robert J Martin26 shared
John P Mistler22 shared
Sean R Marcsisin9 shared
Jonah S Ufferfilge6 shared
Daniel L Zheng5 shared
Dien N Nguyen5 shared
Armen H Youssoufian4 shared
Jonathan G Matrisciano4 shared
Josh Renzo N Ramilo3 shared
Syeda N Mahazabin2 shared
Full investigator report
Get the verbatim findings behind Erik W Koester's 531 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