FDA Person
Department of Health and Human ServicesHelen B. Ricalde
View detailed information about Helen B. Ricalde, including compliance records, violations, and related data.
Person Profile
FDA investigator, Department of Health and Human Services. Took part in 19 inspections of 19 companies, 2016–2023.
Inspections (19)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| October 17, 2023 | Alk-abello, Inc. | VAI | Vaccines and Allergenic Products | #1220460 |
| June 16, 2023 | Bristol-Myers Squibb Company | VAI | Human Cellular, Tissue, and Gene Therapies | #1208871 |
| September 7, 2018 | Ecometics, Inc. | Not classified | Drug Quality Assurance | #1065238 |
| July 19, 2018 | Richmond VA Medical Center | VAI | Drug Quality Assurance | #1060421 |
| May 25, 2018 | Merck Serono S.p.A. | VAI | Drug Quality Assurance | #1053903 |
| April 9, 2018 | Marietta Corp | VAI | Drug Quality Assurance | #1054316 |
| April 9, 2018 | Marietta Corporation | VAI | Drug Quality Assurance | #1047585 |
| February 28, 2018 | Chartwell Pharmaceuticals Carmel LLC | VAI | Drug Quality Assurance | #1043109 |
| December 1, 2017 | Professional Disposables International, Inc. | VAI | Drug Quality Assurance | #1040815 |
| September 22, 2017 | Epax Norway AS | VAI | Drug Quality Assurance | #1029746 |
| September 15, 2017 | Estee Lauder N.V. | VAI | Drug Quality Assurance | #1030311 |
| September 7, 2017 | Eurofins PROXY Laboratories B.V. | VAI | Drug Quality Assurance | #1028845 |
| July 3, 2017 | BAYER PHARMA, AG | Not classified | #1023408 | |
| June 22, 2017 | Patheon Inc. | Not classified | #1029053 | |
| March 30, 2017 | Fresenius Kabi USA, LLC | VAI | Drug Quality Assurance | #1014707 |
| March 16, 2017 | Strides Pharma, Inc. | VAI | Drug Quality Assurance | #1009619 |
| January 26, 2017 | Barr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals) | NAI | Drug Quality Assurance | #1001828 |
| December 21, 2016 | Jd888 LLC | VAI | Drug Quality Assurance | #996733 |
| November 1, 2016 | Chartwell Pharmaceuticals LLC | VAI | Bioresearch Monitoring | #992472 |
Documents (15)
- EIR · Ajinomoto Althea, Inc. · June 11, 2013
- 483 · Unknown Company · July 19, 2018
- 483 · Hunter Holmes McGuire Veterans Affairs Medical Center Mammography · July 19, 2018
- 483 · Unknown Company · August 22, 2014
- EIR · Chartwell Pharmaceuticals LLC · November 1, 2016
- 483 · Chartwell Pharmaceuticals Carmel LLC · February 28, 2018
- EIR · Chartwell Pharmaceuticals Carmel LLC · November 2, 2015
- 483 · Dendreon Corporation
- 483 · Bristol-Myers Squibb Company · June 16, 2023
- 483 · Eurofins PROXY Laboratories B.V. · September 7, 2017
- EIR · Chartwell Pharmaceuticals Carmel LLC · February 28, 2018
- EIR · Fresenius Kabi USA, LLC · March 30, 2017
- 483 · Ecometics, Inc. · September 7, 2018
- 483 · Fresenius Kabi USA, LLC · March 30, 2017
- 483 · Dendreon Corporation
Frequently inspected with (6)
Christian Lynch
1 shared
Emily A. Walters
issuing_officer
1 shared
Erika E. Englund
1 shared
Louis G. An
1 shared
Mindy M. Chou
1 shared
Unnee Ranjan
Investigator
1 shared
Related Office
Person Information
Name
Helen B. Ricalde
Title
Director, Team Biologics Staff
Role
Regulatory Personnel
ID: 455f022e-4d32-453e-acc7-e84a53ce730c
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