FDA Person
FDATracy K. Li
View detailed information about Tracy K. Li, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 20 inspections of 20 companies, 2016–2019.
Inspections (20)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| January 28, 2019 | Pet Pharmacy NW LLC | OAI | Drug Quality Assurance | #1080137 |
| November 1, 2018 | Innocosma, Inc. | NAI | Drug Quality Assurance | #1071688 |
| September 28, 2018 | Maag Prescription Center LLC | VAI | Drug Quality Assurance | #1067395 |
| August 28, 2018 | Pharm D Solutions, LLC | OAI | Drug Quality Assurance | #1063709 |
| July 5, 2018 | Genentech, Inc. | VAI | Drug Quality Assurance | #1057924 |
| May 18, 2018 | Alembic Pharmaceuticals Ltd (API Division, Karakhadi) | VAI | Drug Quality Assurance | #1055638 |
| May 11, 2018 | Unique Chemicals | VAI | Drug Quality Assurance | #1055637 |
| May 4, 2018 | Sun Pharmaceutical Industries Ltd. | NAI | Drug Quality Assurance | #1055452 |
| April 20, 2018 | Magno-Humphries Inc. | VAI | Drug Quality Assurance | #1049556 |
| February 16, 2018 | Yusef Manufacturing Laboratories, LLC | Not classified | Drug Quality Assurance | #1041369 |
| November 21, 2017 | Trone Health Services, Inc. | Not classified | #1032022 | |
| September 25, 2017 | Industrial Source | NAI | Drug Quality Assurance | #1029360 |
| September 21, 2017 | Jubilant HollisterStier LLC | VAI | New Drug Evaluation | #1026132 |
| August 15, 2017 | Dynamic Nutritional Associates Inc. | VAI | Drug Quality Assurance | #1023324 |
| July 12, 2017 | JD & SN Inc. | Not classified | #1020623 | |
| May 18, 2017 | Option Care Enterprises, Inc. | Not classified | #1014962 | |
| April 14, 2017 | HTO Nevada Inc | VAI | Drug Quality Assurance | #1010178 |
| March 1, 2017 | Compound Preferred LLC | OAI | Drug Quality Assurance | #1005663 |
| December 14, 2016 | VitaCare Labs Inc. | VAI | Drug Quality Assurance | #1000896 |
| December 6, 2016 | BWXT Medical Ltd. | VAI | Drug Quality Assurance | #1000973 |
Documents (16)
- 483 · Montana Compounding Pharmacy P.C. · September 20, 2016
- 483 · Maag Prescription Center LLC · September 28, 2018
- 483 · Montana Compounding Pharmacy PC · May 8, 2015
- 483 · Trone Health Services, Inc. · July 15, 2016
- 483 · JD & SN Inc. · July 12, 2017
- 483 · Trone Health Services, Inc. · November 21, 2017
- 483 · Option Care Enterprises, Inc. · May 18, 2017
- 483 RESPONSE · Compound Preferred LLC · March 1, 2017
- 483 · Compound Preferred LLC · March 1, 2017
- WARNING LETTER · Oregon’s Wild Harvest, Inc. · September 24, 2021
- WARNING LETTER · R-Garden LLC · August 15, 2019
- 483 · Pharm D Solutions, LLC · August 28, 2018
- EIR · Jubilant HollisterStier LLC · September 21, 2017
- 483 · Beal G. Essink, MD · November 6, 2014
- EIR · Lonza Bend Inc · June 3, 2016
- 483 · Jubilant HollisterStier LLC · September 21, 2017
Frequently inspected with (7)
Person Information
Name
Tracy K. Li
Title
Senior Director, Precision Medicine and Innovative Strategies
Role
Regulatory Personnel
ID: dce1757a-bb2a-462c-868c-bae77168a764
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