Overview
- 338 inspections across 286 sites are on record.
- 385 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2020-02-07.
At a glance
Inspections
338
Sites
286
Observations
385
Career since
Feb 2009
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Biotest Pharmaceuticals Corporation | 7 Feb 2020 | Biologics | |
| Grifols | 15 Jan 2020 | Biologics | |
| South Dakota Lions Eye Bank, Inc. | 13 Dec 2019 | Biologics | |
| BioLife Plasma Services L.P. | 22 Nov 2019 | Biologics | |
| South Dakota Lions Eye and Tissue Bank Inc. | 21 Nov 2019 | Biologics |
Sites inspected
Biotest Pharmaceuticals CorporationBrookings, United States1 insp.
GrifolsCouncil Bluffs, United States1 insp.
South Dakota Lions Eye Bank, Inc.Sioux Falls, United States1 insp.
BioLife Plasma Services L.P.West Fargo, United States1 insp.
South Dakota Lions Eye and Tissue Bank Inc.Bismarck, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
John E Emmert17 shared
Wayne W Grundstrom14 shared
Karen M Labounty6 shared
Amy L Mcintyre5 shared
Mada A Tautges4 shared
Dianna C Sonnenburg3 shared
Karla J Youngberg2 shared
Grant M Ruis2 shared
Christina A Castineyra2 shared
Brent T Hall1 shared
Full investigator report
Get the verbatim findings behind Traci C Kelm's 385 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