Lu Chen
FDA investigator
Appears on 4 documents from 2024 to 2026, mostly at sites in Pennsylvania. Most often cites responsibilities of quality control unit (21 CFR 211.22).
- 4
- Documents on file
- 5.8
- Observations per 483
- 2024
- First seen
- 2026
- Most recent
What they cite most
From 23 observations- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.160General requirements3
- 21 CFR 211.67(b)(3)Equipment cleaning and maintenance3
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.165Testing and release for distribution2
Activity by year
2024: 1, 2025: 2, 2026: 1
Where
Pennsylvania 4
Often inspects with
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Inspection history
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-01-14 | 483 US Specialty Formulations LLCJan 14, 2026 · Allentown, Pennsylvania | Allentown, Pennsylvania | 7 | |
| 2025-03-26 | 483 US Specialty Formulations LLCMar 26, 2025 · Allentown, Pennsylvania | Allentown, Pennsylvania | 5 | |
| 2025-03-26 | 483 US Specialty Formulations LLCMar 26, 2025 · Allentown, Pennsylvania | Allentown, Pennsylvania | 5 | |
| 2024-10-15 | 483 Straight Arrow Products, Inc.Oct 15, 2024 · Easton, Pennsylvania | Easton, Pennsylvania | 6 |
About this profile
What does Lu Chen inspect?
Lu Chen appears on 4 documents on file covering 2 sites, mostly in Pennsylvania.
What do they cite most often?
21 CFR 211.22 (responsibilities of quality control unit), followed by 21 CFR 211.160 and 21 CFR 211.67(b)(3).
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 Lu Chen is dated Jan 14, 2026.