Lori M. Newman
FDA investigator
Appears on 18 documents from 2021 to 2026, most often at sites in Massachusetts. Most often cites production record review (21 CFR 211.192).
- 18
- Documents on file
- 7.5
- Observations per 483
- 2021
- First seen
- 2026
- Most recent
What they cite most
From 130 observations- 21 CFR 211.192Production record review16
- 21 CFR 211.42(a)Design and construction features14
- 21 CFR 211.113Control of microbiological contamination11
- 21 CFR 211.160General requirements11
- 21 CFR 211.67Equipment cleaning and maintenance10
- 21 CFR 211.22Responsibilities of quality control unit9
Activity by year
2021: 2, 2022: 2, 2023: 4, 2024: 5, 2025: 4, 2026: 1
Where
Massachusetts 3 · New Hampshire 3 · India 2 · New York 2 · Rhode Island 2 · Connecticut 1
Often inspects with
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Inspection history
18 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-04-09 | 483 Lantheus Medical Imaging, Inc.Apr 9, 2026 | — | 7 | |
| 2025-11-06 | 483 Fresenius Kabi Compounding, LLCNov 6, 2025 · Canton, Massachusetts | Canton, Massachusetts | 7 | |
| 2025-11-05 | 483 Fresenius Kabi Compounding, LLCNov 5, 2025 · Canton, Massachusetts | Canton, Massachusetts | 7 | |
| 2025-04-11 | 483 NTP RADIOISOTOPESApr 11, 2025 · BRITS, South Africa | BRITS, South Africa | — | |
| 2025-01-17 | 483 SpecGx LLCJan 17, 2025 · Hobart, New York | Hobart, New York | 4 | |
| 2024-07-29 | 483 Denison Pharmaceuticals, LLCJul 29, 2024 · Lincoln, Rhode Island | Lincoln, Rhode Island | 11 | |
| 2024-05-22 | 483 Tom's of Maine, Inc.May 22, 2024 · Sanford, Maine | Sanford, Maine | 4 |
About this profile
What does Lori M. Newman inspect?
Lori M. Newman appears on 18 documents on file covering 16 sites, most often in Massachusetts.
What do they cite most often?
21 CFR 211.192 (production record review), followed by 21 CFR 211.42(a) and 21 CFR 211.113.
Can I read the observations?
Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.
How current is this profile?
The most recent document on file for Lori M. Newman is dated Apr 9, 2026.