Scott R. Nichols
FDA investigator
Appears on 4 documents from 2017 to 2019, most often at sites in Austria. Most often cites written procedures; deviations (21 CFR 211.100).
- 4
- Documents on file
- 3.8
- Observations per 483
- 2017
- First seen
- 2019
- Most recent
What they cite most
From 15 observations- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.192Production record review3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.186Master production and control records2
- 21 CFR 211.46Ventilation, air filtration, air heating and cooling1
- 21 CFR 211.67Equipment cleaning and maintenance1
Activity by year
2017: 1, 2018: 1, 2019: 2
Where
Austria 1 · India 1 · Indiana 1 · Maryland 1
Often inspects with
Is Scott R. Nichols 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
4 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-09-19 | 483 Biocon Biologics LimitedSep 19, 2019 · Bengaluru, India | Bengaluru, India | 8 | |
| 2019-03-15 | 483 Human Genome Sciences, Inc.Mar 15, 2019 · Rockville, Maryland | Rockville, Maryland | 2 | |
| 2018-05-01 | 483 Cook Pharmica LLCMay 1, 2018 · Bloomington, Indiana | Bloomington, Indiana | 4 | |
| 2017-10-13 | 483 Sandoz GmbHOct 13, 2017 · Langkampfen, Austria | Langkampfen, Austria | 1 |
About this profile
What does Scott R. Nichols inspect?
Scott R. Nichols appears on 4 documents on file covering 4 sites, most often in Austria.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.192 and 21 CFR 211.22.
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 Scott R. Nichols is dated Sep 19, 2019.