FDA Person
Office of the CommissionerFelix Maldonado
View detailed information about Felix Maldonado, including compliance records, violations, and related data.
Person Profile
FDA investigator, Office of the Commissioner. Took part in 32 inspections of 32 companies, 2016–2019.
Inspections (32)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| August 9, 2019 | Cadila Pharmaceuticals Limited | VAI | Drug Quality Assurance | #1102381 |
| July 30, 2019 | Orchid Pharma Ltd. | VAI | Drug Quality Assurance | #1101410 |
| June 13, 2019 | BLI International, Inc. | NAI | Drug Quality Assurance | #1095698 |
| February 27, 2019 | Eurofins Biopharma Product Testing India Private Ltd. | NAI | Drug Quality Assurance | #1085309 |
| February 22, 2019 | Softgel Healthcare Private Limited | VAI | Drug Quality Assurance | #1080044 |
| February 15, 2019 | Sun Pharmaceutical Industries Limited- Madhuranthagam | NAI | Drug Quality Assurance | #1083591 |
| December 7, 2018 | Haupt Pharma Wuelfing GmbH | NAI | Drug Quality Assurance | #1088285 |
| November 27, 2018 | Bracco Suisse SA | NAI | Drug Quality Assurance | #1086604 |
| September 14, 2018 | Jilin Beisha Pharmaceutical Co. | NAI | Pre-Approval Eval. of Animal Drugs and Food Additives | #1070204 |
| September 6, 2018 | Cisen Pharmaceuticals Co Ltd | Not classified | #1069680 | |
| August 31, 2018 | Henan Lvyuan Pharmaceutical Co., Ltd. | VAI | Drug Quality Assurance | #1068185 |
| July 13, 2018 | BASF SE | VAI | Drug Quality Assurance | #1061372 |
| July 6, 2018 | Corden Pharma GmbH | NAI | Drug Quality Assurance | #1062340 |
| May 3, 2018 | Amneal Pharmaceuticals Private Ltd. | NAI | Drug Quality Assurance | #1056320 |
| April 27, 2018 | Shashi Phytochemical Industries | VAI | Drug Quality Assurance | #1054539 |
| April 20, 2018 | Unichem Laboratories Ltd. | NAI | Drug Quality Assurance | #1053321 |
| March 29, 2018 | ICON Laboratory Services, Inc. | NAI | Drug Quality Assurance | #1047602 |
| December 1, 2017 | Gopaldas Visram & Co., Ltd. | VAI | Drug Quality Assurance | #1034625 |
| November 24, 2017 | SGS India Private Limited | NAI | Drug Quality Assurance | #1041917 |
| November 20, 2017 | Rubicon Research Private Limited | NAI | Drug Quality Assurance | #1038536 |
Documents (9)
- 483 · Sun Pharmaceutical Industries Limited · November 16, 2016
- EIR · SGS India Private Limited · November 24, 2017
- 483 · Fresenius Kabi USA, LLC · July 8, 2011
- EIR · BASF SE · July 13, 2018
- 483 · Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)
- 483 · Softgel Healthcare Private Limited · February 22, 2019
- 483 · Steriscience Specialties Private Limited · September 1, 2015
- EIR · Haupt Pharma Wuelfing GmbH · December 7, 2018
- 483 · Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) · July 18, 2013
Frequently inspected with (4)
Related Office
Person Information
Name
Felix Maldonado
Title
Chemist at US Department of Health and Human Services
Role
Regulatory Personnel
ID: d7a5c4bd-2aa7-405f-b3c4-17ef35152ab4
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