Kwong P. Lee
FDA investigator
Appears on 12 documents from 2015 to 2026, mostly at sites in New York. Most often cites design controls (21 CFR 820.30(c)).
- 12
- Documents on file
- 3.2
- Observations per 483
- 2015
- First seen
- 2026
- Most recent
What they cite most
From 38 observations- 21 CFR 820.30(c)Design controls8
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?7
- 21 CFR 820.198(a)Complaint files5
- 21 CFR 820.184Device history record3
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.120(b)Device labeling2
Activity by year
2015: 1, 2016: 1, 2019: 1, 2020: 3, 2021: 1, 2022: 2, 2023: 2, 2026: 1
Where
New York 9 · Connecticut 1 · Massachusetts 1 · New Jersey 1
Is Kwong P. Lee coming to your site?
Our team writes custom reports before an inspection: what this investigator cites most, how they write it up, and how your site's history compares, in one brief you can circulate.
Ask about any investigator in Claude or ChatGPT with the AI connector.
Inspection history
12 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-03-03 | 483 Medivis, IncMar 3, 2026 · New York, New York | New York, New York | 2 | |
| 2023-07-12 | 483 Form 483 · FEI 3017580485Jul 12, 2023 · Amherst, Massachusetts | Amherst, Massachusetts | 9 | |
| 2023-02-10 | 483 Biodex Medical Systems, IncFeb 10, 2023 · Shirley, New York | Shirley, New York | 2 | |
| 2022-11-08 | 483 HansBiomed USA, IncNov 8, 2022 · Englewood Cliffs, New Jersey | Englewood Cliffs, New Jersey | 4 | |
| 2022-10-24 | 483 Perrigo New York, Inc.Oct 24, 2022 · Bronx, New York | Bronx, New York | 1 | |
| 2021-05-13 | 483 Koios Medical, IncMay 13, 2021 · New York, New York | New York, New York | 2 | |
| 2020-11-12 | 483 Advanced Monitored Caregiving, IncNov 12, 2020 · New York, New York | New York, New York | 1 |
About this profile
What does Kwong P. Lee inspect?
Kwong P. Lee appears on 12 documents on file covering 11 sites, mostly in New York.
What do they cite most often?
21 CFR 820.30(c) (design controls), followed by 21 CFR 803.17 and 21 CFR 820.198(a).
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 Kwong P. Lee is dated Mar 3, 2026.