Kristen Nickens
FDA investigator
Appears on 3 documents from 2017 to 2024, most often at sites in India. Most often cites written procedures; deviations (21 CFR 211.100).
- 3
- Documents on file
- 2.7
- Observations per 483
- 2017
- First seen
- 2024
- Most recent
What they cite most
From 8 observations- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
Activity by year
2017: 1, 2020: 1, 2024: 1
Where
India 1 · Maryland 1 · Minnesota 1
Often inspects with
Is Kristen Nickens 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
3 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-06-07 | 483 AstraZeneca Pharmaceuticals LP Frederick Manufacturing Cente /'Jun 7, 2024 · Frederick, Maryland | Frederick, Maryland | 4 | |
| 2020-03-18 | 483 Takeda Pharmaceuticals U.S.A., Inc.Mar 18, 2020 · Brooklyn Park, Minnesota | Brooklyn Park, Minnesota | 3 | |
| 2017-04-07 | 483 Biocon LimitedApr 7, 2017 · Bangalore, India | Bangalore, India | 1 |
About this profile
What does Kristen Nickens inspect?
Kristen Nickens appears on 3 documents on file covering 3 sites, most often in India.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.192 and 21 CFR 211.67.
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 Kristen Nickens is dated Jun 7, 2024.