Nicholas Violand
FDA investigator
Appears on 17 documents from 2013 to 2022, mostly at sites in New Jersey. Most often cites control of microbiological contamination (21 CFR 211.113).
- 17
- Documents on file
- 5.3
- Observations per 483
- 2013
- First seen
- 2022
- Most recent
What they cite most
From 93 observations- 21 CFR 211.113Control of microbiological contamination9
- 21 CFR 211.160General requirements8
- 21 CFR 211.192Production record review8
- 21 CFR 211.22Responsibilities of quality control unit8
- 21 CFR 211.42Design and construction features8
- 21 CFR 211.68Automatic, mechanical, and electronic equipment8
Activity by year
2013: 2, 2014: 1, 2016: 4, 2017: 3, 2018: 2, 2019: 2, 2021: 1, 2022: 2
Where
New Jersey 11 · India 2 · Maryland 2 · Pennsylvania 1
Often inspects with
Emmanuel J. Ramos· Michael R. Klapal· Patric C. Klotzbuecher
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Inspection history
17 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-12-20 | 483 Health Pharma USA LLCDec 20, 2022 · Rahway, New Jersey | Rahway, New Jersey | 14 | |
| 2022-05-17 | 483 Akorn Operating Company LLC (dba Akorn)May 17, 2022 · Somerset, New Jersey | Somerset, New Jersey | — | |
| 2021-07-08 | 483 Novitium Pharma LLCJul 8, 2021 · East Windsor, New Jersey | East Windsor, New Jersey | 1 | |
| 2019-04-16 | 483 KVK-Tech, IncApr 16, 2019 · Newtown, Pennsylvania | Newtown, Pennsylvania | 7 | |
| 2019-02-14 | 483 ONESOURCE SPECIALTY PHARMA LIMITEDFeb 14, 2019 · Bengaluru, India | Bengaluru, India | 1 | |
| 2018-11-06 | 483 APPCO PHARMA LLCNov 6, 2018 · Piscataway, New Jersey | Piscataway, New Jersey | 2 | |
| 2018-03-15 | 483 Renaissance Lakewood, LLCMar 15, 2018 · Lakewood, New Jersey | Lakewood, New Jersey | 1 |
About this profile
What does Nicholas Violand inspect?
Nicholas Violand appears on 17 documents on file covering 15 sites, mostly in New Jersey.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.160 and 21 CFR 211.192.
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 Violand is dated Dec 20, 2022.