FDA Person
FDASimone E. Pitts
View detailed information about Simone E. Pitts, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 35 inspections of 35 companies, 2016–2026.
Inspections (35)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| August 18, 2026 | Imprimis NJOF, LLC | Not classified | #1316136 | |
| April 21, 2026 | American Regent, Inc. | Not classified | Drug Quality Assurance | #1313930 |
| March 13, 2026 | SCA Pharmaceuticals, LLC | Not classified | Drug Quality Assurance | #1307176 |
| December 9, 2025 | Novo Nordisk US Bio Production Inc. | Not classified | #1292060 | |
| August 22, 2025 | Nephron Sc Inc | Not classified | Drug Quality Assurance | #1274364 |
| April 29, 2025 | Hainan Simcere Pharmaceutical Co., Ltd. | Not classified | #1272074 | |
| April 25, 2025 | Fujian Kerui Pharmaceutical Co., Ltd. | Not classified | #1272065 | |
| April 18, 2025 | Pucheng Chia Tai Biochemical Co. Ltd. - Putan Factory | Not classified | #1271492 | |
| February 21, 2025 | R.S.A. Corp. | Not classified | #1266088 | |
| September 30, 2024 | Pine Pharmaceuticals, LLC | OAI | Drug Quality Assurance | #1246936 |
| August 29, 2024 | Novo Nordisk Pharmaceutical Industries LP | VAI | New Drug Evaluation | #1248200 |
| July 17, 2024 | Davion Inc | VAI | Drug Quality Assurance | #1243953 |
| November 2, 2023 | UPSIDE FOODS | NAI | Foodborne Biological Hazards | #1224133 |
| September 1, 2023 | Prime Matter Labs | VAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1216813 |
| August 15, 2019 | University of Missouri - Columbia Research Reactor Center | VAI | Drug Quality Assurance | #1100816 |
| August 14, 2019 | NorthStar Medical Radioisotopes, LLC | VAI | Drug Quality Assurance | #1101973 |
| June 14, 2019 | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd. | VAI | Drug Quality Assurance | #1106763 |
| March 29, 2019 | ARx LLC | VAI | Generic Drug Evaluation | #1085673 |
| November 9, 2018 | Pharmaceutics International, Inc. | VAI | Drug Quality Assurance | #1072073 |
| November 9, 2018 | Pharmaceutics International Inc | VAI | New Drug Evaluation | #1071297 |
Documents (39)
- 483 · Nephron Sc Inc · August 22, 2025
- 483 · SCA Pharmaceuticals, LLC · March 13, 2026
- 483 · Professional Disposables International, Inc. · December 18, 2006
- EIR · Pharmaceutics International, Inc. · November 14, 2022
- EIR · Pharmaceutics International, Inc. · November 9, 2018
- EIR · Pharmaceutics International Inc · November 14, 2022
- 483 · Pucheng Chia Tai Biochemical Co. Ltd. - Putan Factory · April 18, 2025
- 483 · UCB Pharma S.A.
- 483 · Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.
- 483 · Granulation Technology, Inc. · March 2, 2023
- 483 · NAMSA
- 483 · University of Missouri - Columbia Research Reactor Center · August 15, 2019
- 483 · Seqirus Inc
- 483 · Pharmaceutics International Inc · November 9, 2018
- 483 · R.S.A. Corp. · February 21, 2025
- 483 · Novo Nordisk Pharmaceutical Industries LP · August 29, 2024
- 483 · GRANULATION TECHNOLOGY, INC. · March 2, 2023
- 483 · Allermed Laboratories, Inc.
- 483 · Davion Inc · July 17, 2024
- 483 · Barr Laboratories Inc.
- 483 · ARx LLC · March 29, 2019
- 483 · Novo Nordisk US Bio Production Inc. · December 9, 2025
- 483 · Prime Matter Labs · September 1, 2023
- 483 · Baxter Pharmaceutical Solutions, LLC
- 483 · LifeSouth Community Blood Centers, Inc
- 483 · Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) · November 2, 2017
- 483 · NorthStar Medical Radioisotopes, LLC · August 14, 2019
- EIR · Hospira, Inc., A Pfizer Company · January 17, 2020
- 483 · StemGenex Biologic Laboratories, LLC · January 26, 2018
- 483 · Fibrocell Technologies, Inc.
- 483 · Pharmaceutics International Inc · November 14, 2022
- EIR · AGC Biologics A/S · November 7, 2017
- 483 · Amsino Healthcare (USA) Inc · December 19, 2022
- 483 · Pharmaceutics International, Inc. · November 14, 2022
- 483 · Hospira, Inc., A Pfizer Company · January 17, 2020
- 483 · American Regent, Inc. · April 21, 2026
- 483 · Merck Sharp & Dohme LLC · April 17, 2015
- 483 · Imprimis NJOF, LLC · August 18, 2026
- 483 · Pine Pharmaceuticals, LLC · September 30, 2024
Frequently inspected with (10)
Alice S. Tsao
Consumer Safety Officer at FDA
3 shared
Alison N. Stieg
Staff Director
2 shared
David A. Oluwo
Pharmacy Intern/Certified Pharmacy Technician
2 shared
Jacqueline M. Diaz Albertini
investigator
2 shared
James Norman
2 shared
Jonathan G Gayechuway
2 shared
Michael Shanks
2 shared
Peng Zhou
2 shared
Susan M. Jackson
investigator
2 shared
Vivin George
2 shared
Person Information
Name
Simone E. Pitts
Title
National Expert, Pharmaceutical
Role
Regulatory Personnel
ID: e405f1fc-4aff-4202-b216-ddbdc342d108
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