Overview
- 10 inspections across 9 sites are on record.
- 47 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2023-02-10.
At a glance
Inspections
10
Sites
9
Observations
47
Career since
Aug 2021
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Nephron Sterile Compounding Center, LLC | 10 Feb 2023 | Human Drugs | View 483 → |
| Biogen U.S. Corporation | 26 Aug 2022 | Human Drugs | On file |
| Biogen U.S. Corporation | 19 Aug 2022 | Human Drugs | View 483 → |
| Inspec Solutions LLC. | 1 Jul 2022 | Human Drugs | View 483 → |
| Kobayashi America Manufacturing, LLC | 27 May 2022 | Human Drugs | View 483 → |
Sites inspected
Nephron Sterile Compounding Center, LLCWest Columbia, United States1 insp.
Biogen U.S. CorporationDurham, United States2 insp.
Inspec Solutions LLC.Holly Hill, United States1 insp.
Kobayashi America Manufacturing, LLCDalton, United States1 insp.
Co-investigators
Investigators who share inspections with this person.
Veronica Fuentes4 shared
Sonya M Edmonds2 shared
Mary-Jeanet Mcgarry1 shared
Melanie M Walker1 shared
Clifton L Randell1 shared
Jamie L Port1 shared
June P Page1 shared
Esther C Broner1 shared
Wendy G Tan1 shared
Ileana Barreto-Pettit1 shared
Full investigator report
Get the verbatim findings behind Song Y Lavalais' 47 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