Overview
- 50 inspections across 48 sites are on record.
- 92 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2017-01-11.
At a glance
Inspections
50
Sites
48
Observations
92
Career since
Oct 2014
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Columbia Cosmetics Manufacturing, Inc. | 11 Jan 2017 | Human Drugs | View 483 → |
| Bayer HealthCare LLC | 13 Dec 2016 | Human Drugs | On file |
| Kaiser Foundation Hospitals | 27 Oct 2016 | Human Drugs | View 483 → |
| PETNET Solutions, Inc. | 28 Sep 2016 | Human Drugs | |
| All Points Manufacturing, LLC. | 19 Jul 2016 | Foods & Cosmetics | View 483 → |
Sites inspected
Columbia Cosmetics Manufacturing, Inc.San Leandro, United States1 insp.
Bayer HealthCare LLCBerkeley, United States1 insp.
Kaiser Foundation HospitalsLivermore, United States1 insp.
PETNET Solutions, Inc.Palo Alto, United States1 insp.
All Points Manufacturing, LLC.Vallejo, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
David Eng3 shared
Ashar P Parikh3 shared
Jeanmaire Hryshko2 shared
Rumany C Penn2 shared
Brian R Henderson2 shared
Siobhan A Gallagher2 shared
Elodie X Tong Lin2 shared
Maridali Deleon-Torres2 shared
Maridali De Leon-Torres2 shared
Steven M Galvez2 shared
Full investigator report
Get the verbatim findings behind James C Lee's 92 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