Nicholas Z. Lu
FDA investigator
Appears on 10 documents from 2018 to 2024, most often at sites in Illinois. Most often cites design controls (21 CFR 820.30).
- 10
- Documents on file
- 5.1
- Observations per 483
- 2018
- First seen
- 2024
- Most recent
What they cite most
From 51 observations- 21 CFR 820.30Design controls8
- 21 CFR 820.100Corrective and preventive action7
- 21 CFR 820.20(a)Management responsibility5
- 21 CFR 820.70(a)Production and process controls5
- 21 CFR 820.75(a)Process validation4
- 21 CFR 820.198(a)Complaint files3
Activity by year
2018: 1, 2019: 1, 2022: 4, 2024: 4
Where
Illinois 4 · Wisconsin 4 · Colorado 1 · Mississippi 1
Often inspects with
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Inspection history
10 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-12-17 | 483 Sterigenics U.S., LLCDec 17, 2024 · Schaumburg, Illinois | Schaumburg, Illinois | 1 | |
| 2024-11-07 | 483 Commercial Plastics Kenosha LLCNov 7, 2024 · Kenosha, Wisconsin | Kenosha, Wisconsin | 5 | |
| 2024-09-03 | 483 Dental Health Associates Of Madison, LtdSep 3, 2024 · Fitchburg, Wisconsin | Fitchburg, Wisconsin | 4 | |
| 2024-03-01 | 483 Optikem International, Inc.Mar 1, 2024 · Denver, Colorado | Denver, Colorado | 7 | |
| 2022-10-18 | 483 Patrin Pharma, IncOct 18, 2022 · Niles, Illinois | Niles, Illinois | 3 | |
| 2022-09-30 | 483 Oak Ridge ProductsSep 30, 2022 · McHenry, Illinois | McHenry, Illinois | 8 | |
| 2022-07-29 | 483 Cytophil, Inc.Jul 29, 2022 · East Troy, Wisconsin | East Troy, Wisconsin | 5 |
About this profile
What does Nicholas Z. Lu inspect?
Nicholas Z. Lu appears on 10 documents on file covering 10 sites, most often in Illinois.
What do they cite most often?
21 CFR 820.30 (design controls), followed by 21 CFR 820.100 and 21 CFR 820.20(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 Nicholas Z. Lu is dated Dec 17, 2024.