FDA Person
Center for Drug Evaluation and ResearchConcepcion Cruz
View detailed information about Concepcion Cruz, including compliance records, violations, and related data.
Person Profile
FDA investigator, Center for Drug Evaluation and Research. Took part in 6 inspections of 6 companies, 2017–2019.
Inspections (6)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| May 14, 2019 | Hetero Labs Ltd. - Unit IX | OAI | Drug Quality Assurance | #1089874 |
| September 29, 2017 | Shandex Personal Care Manufacturing Inc. | NAI | Drug Quality Assurance | #1032398 |
| September 22, 2017 | Bora Pharmaceutical Services Inc. | NAI | Drug Quality Assurance | #1030562 |
| September 15, 2017 | Halo Pharmaceutical Canada Inc | NAI | Drug Quality Assurance | #1030363 |
| May 26, 2017 | Mylan Laboratories Limited (FDF-2) | VAI | Drug Quality Assurance | #1012796 |
| May 16, 2017 | Fleming Laboratories Limited | OAI | Drug Quality Assurance | #1012855 |
Documents (6)
- WARNING LETTER · Kyowa Hakko Kogyo Co., Ltd. · June 25, 2010
- EIR · BASF SE · March 10, 2016
- EIR · PharmaZell GmbH · September 22, 2017
- EIR · American Antibiotics, Inc. · December 18, 2015
- EIR · DSM Nutritional Products France SAS · September 16, 2016
- 483 · Hetero Labs Ltd. - Unit IX · May 14, 2019
Frequently inspected with (3)
Related Office
Person Information
Name
Concepcion Cruz
Title
FDA Alumnus, Principal at ESCODA Consulting Group, and Scientific Advisory Board Member at AiZen Algo
Role
Regulatory Personnel
ID: 831264a6-1a6b-47f1-b0bf-f3091d3b2f1c
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