FDA Person
Office of the CommissionerNicholas A. Violand
View detailed information about Nicholas A. Violand, including compliance records, violations, and related data.
Person Profile
FDA investigator, Office of the Commissioner. Took part in 27 inspections of 27 companies, 2016–2019.
Inspections (27)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 13, 2019 | Kreitchman PET Center | VAI | New Drug Evaluation | #1101937 |
| July 25, 2019 | Shandong Shengli Bio-Engineering Co., Ltd. | NAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1101491 |
| July 18, 2019 | Ruyuan Hec Pharm Co. Ltd. | Not classified | #1100891 | |
| July 16, 2019 | SHANDONG LUYE PHARMACEUTICAL CO., LTD | Not classified | #1107813 | |
| June 3, 2019 | Health Pharma USA LLC | OAI | Drug Quality Assurance | #1092057 |
| April 16, 2019 | KVK Tech, Inc. | OAI | Generic Drug Evaluation | #1086467 |
| February 14, 2019 | Steriscience Specialties Private Limited | VAI | Drug Quality Assurance | #1079813 |
| February 1, 2019 | Emcure Pharmaceuticals Limited | Not classified | #1082800 | |
| November 6, 2018 | Appco Pharma LLC | VAI | Drug Quality Assurance | #1071495 |
| October 12, 2018 | Petnet Solutions, Inc. | NAI | Drug Quality Assurance | #1077148 |
| June 28, 2018 | Argenta Dundee Limited | NAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1071328 |
| June 21, 2018 | Laboratoire Unither | VAI | Drug Quality Assurance | #1057672 |
| May 17, 2018 | Advanced Accelerator Applications USA, Inc. | Not classified | #1054683 | |
| April 13, 2018 | Hikma Pharmaceuticals USA, Inc. | NAI | Drug Quality Assurance | #1054739 |
| March 15, 2018 | Renaissance Lakewood, LLC | VAI | Drug Quality Assurance | #1045720 |
| December 13, 2017 | PharMEDium Services LLC | OAI | Drug Quality Assurance | #1038537 |
| September 20, 2017 | Sintetica S.A. | NAI | Drug Quality Assurance | #1032344 |
| September 15, 2017 | Celgene International Sarl | VAI | Drug Quality Assurance | #1026576 |
| September 8, 2017 | Carbogen Amcis AG | NAI | Drug Quality Assurance | #1037734 |
| August 31, 2017 | Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy | Not classified | #1028862 |
Documents (22)
- 483 · Liberty Drug & Surgical · May 22, 2015
- 483 · Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy · August 31, 2017
- 483 · Colonia Care Pharmacy · April 15, 2016
- 483 · Drugs Are Us, Inc., dba Hopewell Pharmacy · March 21, 2013
- 483 · Wedgewood Village Pharmacy, LLC · February 11, 2013
- 483 · PharMEDium Services LLC · December 13, 2017
- 483 · Cipla Limited · August 30, 2016
- 483 · Indoco Remedies Limited · September 4, 2016
- 483 · Ideal Specialty Apothecary Inc., dba Ideal Pharmacy · August 31, 2017
- EIR · Cipla Limited · August 30, 2016
- 483 · Bora Pharmaceuticals Injectables Inc · August 26, 2014
- 483 · Health Pharma USA LLC · December 20, 2022
- 483 · Akorn Operating Company LLC · May 17, 2022
- 483 · Pharmaceutics International Inc · March 24, 2017
- 483 · Novitium Pharma LLC · July 8, 2021
- 483 · Kreitchman PET Center · September 13, 2019
- 483 · Steriscience Specialties Private Limited · February 14, 2019
- 483 · EuTech Scientific Services Inc · December 28, 2021
- 483 · Appco Pharma LLC · November 6, 2018
- 483 · KVK Tech, Inc. · April 16, 2019
- 483 · Celgene International Sarl · September 15, 2017
- 483 RESPONSE · Colonia Care Pharmacy · February 11, 2016
Frequently inspected with (10)
Adetutu M. Gidado
6 shared
Bijoy Panicker
2 shared
Emmanuel J. Ramos
Compliance Officer at FDA
2 shared
James R. Birkenstamm
2 shared
Michael R. Klapal
Investigator
2 shared
Binh T. Nguyen
Investigator
1 shared
Chaltu N.Wakijra
Senior Program Coordinator
1 shared
David J. Claffey
1 shared
Dhanalakshm Kasi
1 shared
Laura Fontan
investigator
1 shared
Related Office
Person Information
Name
Nicholas A. Violand
Title
Director, Enterprise Regulatory Compliance
Role
Regulatory Personnel
ID: c0c3ee7a-8adb-43d2-974c-06220ef8e8eb
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