James R. Montero
FDA investigator
Appears on 10 documents from 2014 to 2025, mostly at sites in Utah. Most often cites corrective and preventive action (21 CFR 820.100).
- 10
- Documents on file
- 6.1
- Observations per 483
- 2014
- First seen
- 2025
- Most recent
What they cite most
From 60 observations- 21 CFR 820.100Corrective and preventive action7
- 21 CFR 820.30Design controls7
- 21 CFR 820.198Complaint files5
- 21 CFR 820.75Process validation5
- 21 CFR 820.50Purchasing controls4
- 21 CFR 820.80Receiving, in-process, and finished device acceptance4
Activity by year
2014: 1, 2015: 2, 2016: 2, 2019: 1, 2021: 1, 2024: 2, 2025: 1
Where
Utah 6 · California 2 · Germany 1 · Wyoming 1
Often inspects with
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Inspection history
10 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-12-03 | 483 ASEPTIKITS, LLCDec 3, 2025 · North Salt Lake, Utah | North Salt Lake, Utah | 7 | |
| 2024-11-07 | 483 Dexcom, IncNov 7, 2024 · San Diego, California | San Diego, California | 7 | |
| 2024-07-31 | 483 Form 483 · FEI 3021769057Jul 31, 2024 · Cypress, California | Cypress, California | 3 | |
| 2021-02-12 | 483 International Medical Development, Inc. 560 Highway 39Feb 12, 2021 · Huntsville, Utah | Huntsville, Utah | 2 | |
| 2019-06-12 | 483 BPI LabsJun 12, 2019 · Evanston, Wyoming | Evanston, Wyoming | 13 | |
| 2016-03-30 | 483 Novarad CorporationMar 30, 2016 · American Fork, Utah | American Fork, Utah | 7 | |
| 2016-02-19 | 483 Trokamed GmbHFeb 19, 2016 · Geisingen, Germany | Geisingen, Germany | 1 |
About this profile
What does James R. Montero inspect?
James R. Montero appears on 10 documents on file covering 9 sites, mostly in Utah.
What do they cite most often?
21 CFR 820.100 (corrective and preventive action), followed by 21 CFR 820.30 and 21 CFR 820.198.
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 James R. Montero is dated Dec 3, 2025.