Overview
- 20 inspections across 20 sites are on record.
- 21 Form 483 observations are attributed to this investigator.
- Most recent recorded activity is 2019-05-14.
At a glance
Inspections
20
Sites
20
Observations
21
Career since
Sep 2008
Recent inspections
Most recent inspections in the published record.
| Site | Date | Category | Form 483 |
|---|---|---|---|
| Hetero Labs Ltd. - Unit IX | 14 May 2019 | Human Drugs | On file |
| Shandex Personal Care Manufacturing Inc. | 29 Sep 2017 | Human Drugs | |
| Bora Pharmaceutical Services Inc | 22 Sep 2017 | Human Drugs | |
| Halo Pharmaceutical Canada, Inc | 15 Sep 2017 | Human Drugs | |
| Mylan Laboratories Limited | 26 May 2017 | Human Drugs | On file |
Sites inspected
Hetero Labs Ltd. - Unit IXVisakhapatnam, India1 insp.
Shandex Personal Care Manufacturing Inc.Perth, Canada1 insp.
Bora Pharmaceutical Services IncMississauga, Canada1 insp.
Halo Pharmaceutical Canada, IncMirabel, Canada1 insp.
Mylan Laboratories LimitedAurangabad, India1 insp.
Co-investigators
Investigators who share inspections with this person.
Anita R Michael4 shared
Eric L Dong2 shared
Denise M Digiulio2 shared
Jacqueline S Warner2 shared
Rajiv R Srivastava1 shared
Abby E Pelletier1 shared
Milva E Melendez1 shared
Israel Santiago1 shared
Full investigator report
Get the verbatim findings behind Concepcion Cruz's 21 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