FDA Person
FDALaura Fontan
View detailed information about Laura Fontan, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 13 inspections of 13 companies, 2017–2023.
Inspections (13)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| March 21, 2023 | Octapharma Produktionsgesellschaft Deutschland mbH | Not classified | #1207884 | |
| June 14, 2019 | CoreRX Inc. | Not classified | #1105141 | |
| October 18, 2018 | CSL Behring L.L.C. | VAI | Blood and Blood Products | #1072948 |
| May 1, 2018 | Biocon Biologics Limited | VAI | Drug Quality Assurance | #1050980 |
| March 16, 2018 | Eli Lilly Kinsale Ltd. | Not classified | #1046489 | |
| February 20, 2018 | Lek Pharmaceuticals | Not classified | #1045912 | |
| December 8, 2017 | Cilag AG | Not classified | #1046091 | |
| October 27, 2017 | BioMarin International Limited | Not classified | #1030194 | |
| May 16, 2017 | Amgen, Inc. | Not classified | #1017093 | |
| February 17, 2017 | Hovione FarmaCiencia SA | Not classified | #1009651 | |
| February 14, 2017 | Sanofi Winthrop Industrie | Not classified | #1001237 | |
| February 3, 2017 | Alexion Pharma International Operations Unlimited Co. | Not classified | #1002247 | |
| January 26, 2017 | Cosette Pharmaceuticals, Inc. | NAI | Generic Drug Evaluation | #1009132 |
Documents (14)
- 483 · Biocon Biologics Limited · May 1, 2018
- EIR · Pfizer Manufacturing Belgium NV · July 2, 2021
- EIR · CSL Behring L.L.C. · October 18, 2018
- 483 · Eli Lilly Kinsale Ltd. · March 16, 2018
- EIR · Lonza Biologics Porrino SL · September 13, 2016
- 483 · Octapharma Produktionsgesellschaft Deutschland mbH
- 483 · Amgen, Inc. · May 16, 2017
- 483 · Hovione FarmaCiencia SA · March 13, 2017
- 483 · BioMarin Pharmaceutical, Inc.
- 483 · Sandoz GmbH
- 483 · Sandoz GmbH · February 20, 2018
- 483 · CoreRX Inc. · June 14, 2019
- 483 · FinVector Oy
- 483 · FinVector Oy
Frequently inspected with (9)
Yonggang Wang
investigator
2 shared
Adetutu M. Gidado
1 shared
Deyaa Shaheen
Drug Investigator
1 shared
Gregory A. Price
1 shared
Marion Michaelis
1 shared
Michael Shanks
1 shared
Nicholas A. Violand
Director, Enterprise Regulatory Compliance
1 shared
Prabhu P. Raju
Program Expert for Advanced Manufacturing
1 shared
Zainab Y. Mansaray-Storms
1 shared
Person Information
Name
Laura Fontan
Title
investigator
Role
COMPANY REP
ID: b27b02a3-9ab1-49df-b2bc-ee936b69d76a
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