Monica E. Murie
FDA investigator
Appears on 11 documents from 2022 to 2025, mostly at sites in Missouri. Most often cites control of microbiological contamination (21 CFR 211.113).
- 11
- Documents on file
- 3.3
- Observations per 483
- 2022
- First seen
- 2025
- Most recent
What they cite most
From 36 observations- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.192Production record review5
- 21 CFR 211.160General requirements4
- 21 CFR 211.166Stability testing4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.67Equipment cleaning and maintenance3
Activity by year
2022: 2, 2023: 4, 2024: 2, 2025: 3
Where
Missouri 6 · China 2 · Japan 2 · Minnesota 1
Often inspects with
Jacob G. Lutz· Michele L. Glendenning· Michele Perry Williams
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Inspection history
11 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-05-16 | 483 Tokyo Chemical Industry Co., Ltd.May 16, 2025 · Fukaya, Japan | Fukaya, Japan | 2 | |
| 2025-05-09 | 483 KINKANDO CO., LTD.May 9, 2025 · HONJO-SHI, Japan | HONJO-SHI, Japan | 5 | |
| 2025-03-07 | 483 Zhejiang Medicine Co., Ltd. Xinchang Pharmaceutical FactoryMar 7, 2025 · Xinchang, China | Xinchang, China | 1 | |
| 2024-09-13 | 483 Shanghai Chuangshi Medical Technology (Group) Co., Ltd.Sep 13, 2024 · Qingpu, China | Qingpu, China | 3 | |
| 2024-02-06 | 483 Sentio BioSciences LLCFeb 6, 2024 · Maryland Heights, Missouri | Maryland Heights, Missouri | 1 | |
| 2023-12-08 | 483 Patheon Biologics LLCDec 8, 2023 · Saint Louis, Missouri | Saint Louis, Missouri | 3 | |
| 2023-09-18 | 483 SpecGx LLCSep 18, 2023 · Webster Groves, Missouri | Webster Groves, Missouri | 2 |
About this profile
What does Monica E. Murie inspect?
Monica E. Murie appears on 11 documents on file covering 11 sites, mostly in Missouri.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.192 and 21 CFR 211.160.
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 Monica E. Murie is dated May 16, 2025.