Overview
- 18 inspections across 17 sites are on record.
- 0 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2025-06-17.
At a glance
Inspections
18
Sites
17
Observations
0
Career since
May 2010
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Clongen Laboratories LLC | 17 Jun 2025 | Biologics | On file |
| Massbiologics South Coast | 12 Aug 2024 | Biologics | On file |
| Serum Institute of India Private Ltd. | 2 Jul 2024 | Biologics | On file |
| GI Accelerate Memphis LLC | 25 Aug 2023 | Biologics | On file |
| Kite Pharma, Inc. | 4 Mar 2022 | Biologics |
Sites inspected
Clongen Laboratories LLCGaithersburg, United States1 insp.
Massbiologics South CoastFall River, United States1 insp.
Serum Institute of India Private Ltd.Pune, India1 insp.
GI Accelerate Memphis LLCMemphis, United States1 insp.
Kite Pharma, Inc.Frederick, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Wei Wang3 shared
Joan Johnson3 shared
Prajakta A Varadkar2 shared
Graeme E Price2 shared
Michael B Havert2 shared
Arie Menachem2 shared
Vanessa Y Jacobs2 shared
Nicole K Trudel2 shared
Kevin J Matthews1 shared
Carl A Perez1 shared
Full investigator report
Get the verbatim findings behind Donald B Ertel's inspection record
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