Nicole E. Knowlton
FDA investigator
Appears on 36 documents from 2013 to 2026, most often at sites in Florida. Most often cites automatic, mechanical, and electronic equipment (21 CFR 211.68).
- 36
- Documents on file
- 4.9
- Observations per 483
- 2013
- First seen
- 2026
- Most recent
What they cite most
From 175 observations- 21 CFR 211.68Automatic, mechanical, and electronic equipment19
- 21 CFR 211.22Responsibilities of quality control unit16
- 21 CFR 211.100Written procedures; deviations13
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures12
- 21 CFR 211.160General requirements11
- 21 CFR 211.192Production record review11
Activity by year
2013: 1, 2014: 2, 2015: 1, 2017: 3, 2018: 2, 2019: 3, 2020: 1, 2021: 2, 2022: 8, 2023: 6, 2024: 3, 2025: 2, 2026: 2
Where
Florida 15 · India 14 · China 2 · Mexico 2 · Germany 1 · Italy 1
Often inspects with
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Inspection history
36 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2026-02-26 | 483 CoreRX Inc. DBA Bend BioscienceFeb 26, 2026 · Clearwater, Florida | Clearwater, Florida | 7 | |
| 2026-01-30 | 483 Catalent Pharma Solutions, LLCJan 30, 2026 · Saint Petersburg, Florida | Saint Petersburg, Florida | 2 | |
| 2025-03-28 | 483 Acme United CorporationMar 28, 2025 · Brooksville, Florida | Brooksville, Florida | 7 | |
| 2025-02-21 | 483 BPI Labs LLCFeb 21, 2025 · Largo, Florida | Largo, Florida | 1 | |
| 2024-05-14 | 483 Unexo Life Sciences Private Ltd.May 14, 2024 · New Delhi, India | New Delhi, India | 12 | |
| 2024-03-27 | 483 Alkem Laboratories LimitedMar 27, 2024 · Baddi, India | Baddi, India | 1 | |
| 2024-01-19 | 483 Kesin PharmaJan 19, 2024 · Oldsmar, Florida | Oldsmar, Florida | 6 |
About this profile
What does Nicole E. Knowlton inspect?
Nicole E. Knowlton appears on 36 documents on file covering 33 sites, most often in Florida.
What do they cite most often?
21 CFR 211.68 (automatic, mechanical, and electronic equipment), followed by 21 CFR 211.22 and 21 CFR 211.100.
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 Nicole E. Knowlton is dated Feb 26, 2026.