Overview
- 120 inspections across 110 sites are on record.
- 165 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2017-03-31.
At a glance
Inspections
120
Sites
110
Observations
165
Career since
Jun 2009
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Jilin Asymchem Laboratories Co., Ltd. | 31 Mar 2017 | Human Drugs | |
| Shandong Qilu King-phar Pharmaceutical Co., Ltd. | 24 Mar 2017 | Animal Drugs & Feeds | |
| Zhejiang Qimei Commodity Co., Ltd | 15 Mar 2017 | Human Drugs | |
| Recipharm Pharmaservices Private Limited | 9 Feb 2017 | Human Drugs | |
| AIRIS PHARMA PRIVATE LIMITED | 31 Jan 2017 | Human Drugs |
Sites inspected
Jilin Asymchem Laboratories Co., Ltd.Dunhua, China1 insp.
Shandong Qilu King-phar Pharmaceutical Co., Ltd.Jinan, China1 insp.
Zhejiang Qimei Commodity Co., LtdHaining, China1 insp.
Recipharm Pharmaservices Private LimitedBengaluru, India1 insp.
AIRIS PHARMA PRIVATE LIMITEDQuthbullapur Mandal, Hyderabad, India1 insp.
Co-investigators
Investigators who share inspections with this person.
Christian L Witkovskie16 shared
Tamara M Kays10 shared
Lindsey M Schwierjohann8 shared
Anna M Brannen7 shared
Nicholas L Paulin6 shared
Javonica F Penn4 shared
Luckner Jean-Marie3 shared
Craig T Rybus3 shared
Matthew J Zagula3 shared
John E Russell2 shared
Full investigator report
Get the verbatim findings behind Tracey L Harris' 165 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