Walden H. Lee
FDA investigator
Appears on 23 documents from 2013 to 2026, mostly at sites in California. Most often cites testing and release for distribution (21 CFR 211.165).
- 23
- Documents on file
- 6.5
- Observations per 483
- 2013
- First seen
- 2026
- Most recent
What they cite most
From 150 observations- 21 CFR 211.165Testing and release for distribution15
- 21 CFR 211.68Automatic, mechanical, and electronic equipment15
- 21 CFR 211.192Production record review14
- 21 CFR 211.22Responsibilities of quality control unit14
- 21 CFR 211.160General requirements13
- 21 CFR 211.100Written procedures; deviations9
Activity by year
2013: 1, 2015: 1, 2016: 1, 2017: 2, 2018: 1, 2019: 6, 2020: 3, 2021: 2, 2023: 1, 2024: 3, 2026: 2
Where
California 16 · India 2 · Washington 2 · Colorado 1 · Florida 1 · Oklahoma 1
Often inspects with
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Inspection history
23 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-06-17 | 483 Jubilant HollisterStier LLCJun 17, 2026 · Spokane, Washington | Spokane, Washington | 2 | |
| 2026-02-13 | 483 K.C. Pharmaceuticals, Inc.Feb 13, 2026 · Pomona, California | Pomona, California | 13 | |
| 2024-06-06 | 483 Jubilant HollisterStier LLCJun 6, 2024 · Spokane, Washington | Spokane, Washington | 3 | |
| 2024-05-10 | 483 Polypeptide Laboratories IncMay 10, 2024 · Torrance, California | Torrance, California | 1 | |
| 2024-03-01 | 483 Amphastar Pharmaceuticals, Inc.Mar 1, 2024 · Rancho Cucamonga, California | Rancho Cucamonga, California | 6 | |
| 2023-12-18 | 483 Med-Pharmex, IncDec 18, 2023 · Pomona, California | Pomona, California | 4 | |
| 2021-09-14 | 483 Med-Pharmex, IncSep 14, 2021 · Pomona, California | Pomona, California | 13 |
About this profile
What does Walden H. Lee inspect?
Walden H. Lee appears on 23 documents on file covering 16 sites, mostly in California.
What do they cite most often?
21 CFR 211.165 (testing and release for distribution), followed by 21 CFR 211.68 and 21 CFR 211.192.
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 Walden H. Lee is dated Jun 17, 2026.