Kevin T. Le
FDA investigator
Appears on 3 documents from 2026, mostly at sites in Washington. Most often cites requirements for a quality management system (21 CFR 820.10).
- 3
- Documents on file
- 4.7
- Observations per 483
- 2026
- First seen
- 2026
- Most recent
What they cite most
From 14 observations- 21 CFR 820.10Requirements for a quality management system4
- 21 CFR 830.300Devices subject to device identification data submission requirements2
- ISO 13485:2016 Clause 8.2.21
- 21 CFR 820.180General requirements1
- 21 CFR 820.20Management responsibility1
- 21 CFR 820.22Quality audit1
Activity by year
2026: 3
Where
Washington 2 · California 1
Often inspects with
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Inspection history
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-03-11 | 483 Mercator Medsystems, IncMar 11, 2026 · San Leandro, California | San Leandro, California | 1 | |
| 2026-02-20 | 483 Seniorlife Technologies Inc.Feb 20, 2026 · Bellevue, Washington | Bellevue, Washington | 6 | |
| 2026-02-20 | 483 Seniorlife Technologies IncFeb 20, 2026 · Bellevue, Washington | Bellevue, Washington | 7 |
About this profile
What does Kevin T. Le inspect?
Kevin T. Le appears on 3 documents on file covering 2 sites, mostly in Washington.
What do they cite most often?
21 CFR 820.10 (requirements for a quality management system), followed by 21 CFR 830.300 and ISO 13485:2016 Clause 8.2.2.
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 Kevin T. Le is dated Mar 11, 2026.