FDA Person
Department of Health and Human ServicesLori M. Newman
View detailed information about Lori M. Newman, including compliance records, violations, and related data.
Person Profile
FDA investigator, Department of Health and Human Services. Took part in 29 inspections of 28 companies, 2023–2026.
Inspections (29)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| May 8, 2026 | Armstrong Pharmaceuticals, Inc. | VAI | Drug Quality Assurance | #1316472 |
| April 9, 2026 | Lantheus Medical Imaging, Inc. | Not classified | Drug Quality Assurance | #1312058 |
| February 12, 2026 | Tropical Seas, Inc. | OAI | Drug Quality Assurance | #1304354 |
| December 18, 2025 | Shire Human Genetic Therapies, Inc. | Not classified | #1297340 | |
| November 5, 2025 | Fresenius Kabi Compounding, LLC | Not classified | Drug Quality Assurance | #1290368 |
| September 29, 2025 | UL Verification Services | NAI | Drug Quality Assurance | #1286910 |
| September 12, 2025 | Shire Human Genetic Therapies Inc | Not classified | #1281538 | |
| July 30, 2025 | Strem Chemicals, Inc. | OAI | Drug Quality Assurance | #1278370 |
| July 8, 2025 | Bristol-Myers Squibb Company | Not classified | #1272436 | |
| June 5, 2025 | Tedor Pharma, Inc. | VAI | Drug Quality Assurance | #1271887 |
| April 11, 2025 | NTP Radioisotopes | Not classified | #1270254 | |
| April 4, 2025 | Fine Chemicals Corporation | Not classified | #1269438 | |
| March 28, 2025 | Afriplex (Pty) Ltd. | VAI | Drug Quality Assurance | #1265915 |
| March 6, 2025 | Trividia Manufacturing Solutions, Inc. | VAI | Drug Quality Assurance | #1263186 |
| January 17, 2025 | SpecGx, LLC | Not classified | Drug Quality Assurance | #1256233 |
| November 20, 2024 | N-Molecular Inc. d.b.a. SOFIE | VAI | Drug Quality Assurance | #1250020 |
| September 24, 2024 | Arkema, Inc. | Not classified | #1251704 | |
| July 29, 2024 | Denison Pharmaceuticals, LLC | OAI | Drug Quality Assurance | #1240591 |
| May 22, 2024 | Tom's of Maine, Inc. | OAI | Drug Quality Assurance | #1231469 |
| April 4, 2024 | Cipla Limited | VAI | Drug Quality Assurance | #1235546 |
Documents (33)
- 483 · SterRx, LLC · November 4, 2021
- 483 · Zydus Lifesciences Limited · March 27, 2024
- 483 · US Specialty Formulations LLC · April 26, 2022
- 483 · Cipla Limited · April 4, 2024
- 483 · Strem Chemicals, Inc. · July 30, 2025
- 483 · Bristol-Myers Squibb Company · July 8, 2025
- 483 RESPONSE · N-Molecular Inc. d.b.a. SOFIE · November 7, 2024
- 483 · Shire Human Genetic Therapies, Inc. · December 18, 2025
- 483 · Fresenius Kabi Compounding, LLC · November 5, 2025
- EIR · N-Molecular Inc. d.b.a. SOFIE · November 20, 2024
- 483 · NTP Radioisotopes · April 11, 2025
- 483 · Tedor Pharma, Inc. · June 5, 2025
- 483 · Trividia Manufacturing Solutions, Inc. · March 6, 2025
- 483 · The W.S. Badger Company, Inc. · June 1, 2023
- 483 · Bristol-Myers Squibb Company · July 8, 2025
- 483 · Hikma Pharmaceuticals USA Inc. · November 3, 2023
- 483 · Freethink Technologies, Inc. · February 21, 2024
- 483 · Airgas USA, LLC · January 12, 2024
- 483 · Lohxa, LLC · July 19, 2021
- 483 · Pharmasol Corporation · June 14, 2021
- 483 · University Instrumentation Center at UNH · December 5, 2023
- 483 · Denison Pharmaceuticals, LLC · July 29, 2024
- 483 · Pharmasol Corporation · June 14, 2021
- 483 · SpecGx, LLC · January 17, 2025
- 483 · Lohxa, LLC · August 3, 2023
- 483 · Shire Human Genetic Therapies Inc · September 12, 2025
- 483 · ALK-Abello, Inc. · October 21, 2022
- 483 · Denison Pharmaceuticals, LLC · February 9, 2023
- 483 · N-Molecular Inc. d.b.a. SOFIE · November 20, 2024
- 483 · Tom's of Maine, Inc. · May 22, 2024
- 483 · Pace Medical, Inc. · May 7, 2024
- 483 · Tropical Seas, Inc. · February 12, 2026
- 483 · Lantheus Medical Imaging, Inc. · April 9, 2026
Frequently inspected with (10)
Sean R. Marcsisin
Senior Consumer Safety Officer - Pharmaceutical Quality
7 shared
Daniel L. Zheng
M.S., Consumer Safety Officer at FDA
6 shared
Armen H. Youssoufian
2 shared
Edmund F. Mrak
Investigator
2 shared
Ifechimere I. Okafor
investigator
2 shared
Paige R. McCoy
2 shared
Bijoy Panicker
1 shared
James R. Birkenstamm
1 shared
Jessica S. Estriplet
Drug Investigator
1 shared
Jonathan G. Matrisciano
Program Division Director/District Director
1 shared
Related Office
Person Information
Name
Lori M. Newman
Title
Deputy Director
Role
Regulatory Personnel
ID: a0e448e4-11ba-4095-b879-feabb8750b3f
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