FDA Person
FDAAnita Narula
View detailed information about Anita Narula, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 27 inspections of 27 companies, 2016–2019.
Inspections (27)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 26, 2019 | MSD International GmbH (Singapore Branch) | NAI | Drug Quality Assurance | #1109025 |
| September 20, 2019 | Lonza Biologics Tuas Pte Ltd | VAI | Drug Quality Assurance | #1107165 |
| September 14, 2019 | Arch Pharmalabs Limited | Not classified | #1106411 | |
| August 23, 2019 | Oxarc, LLC | VAI | Drug Quality Assurance | #1100516 |
| July 12, 2019 | Eurofins Biopharma Product Testing Munich GmbH | VAI | Drug Quality Assurance | #1096402 |
| July 5, 2019 | C.P.M. Contract Pharma GmbH & Co. KG | VAI | Drug Quality Assurance | #1095436 |
| June 28, 2019 | EUROAPI FRANCE | NAI | Drug Quality Assurance | #1098786 |
| May 24, 2019 | Nitto Avecia Pharma Services, Inc. | Not classified | New Drug Evaluation | #1091017 |
| April 19, 2019 | Herbal Doctor Remedies | Not classified | Drug Quality Assurance | #1087170 |
| March 15, 2019 | Curia New Mexico, LLC | OAI | New Drug Evaluation | #1082939 |
| December 18, 2018 | Results RNA, LLC | OAI | Food Composition, Standards, Labeling and Econ | #1074873 |
| November 2, 2018 | Dendreon Corporation | VAI | Human Cellular, Tissue, and Gene Therapies | #1071020 |
| August 24, 2018 | Boehringer Ingelheim Fremont, Inc. | VAI | Drug Quality Assurance | #1063730 |
| May 4, 2018 | F. Hoffmann - La Roche Ltd. | VAI | Drug Quality Assurance | #1051581 |
| April 24, 2018 | F. Hoffmann-La Roche AG | NAI | Drug Quality Assurance | #1055453 |
| March 16, 2018 | Amgen, Inc. | Not classified | #1046609 | |
| March 1, 2018 | Pacira Pharmaceuticals, Inc. | VAI | Drug Quality Assurance | #1047746 |
| February 9, 2018 | HF Acquisition Co LLC | VAI | Drug Quality Assurance | #1041019 |
| January 25, 2018 | Cardinal Health 414, Inc. | VAI | Drug Quality Assurance | #1038753 |
| September 1, 2017 | Lonza Manufacturing LLC | Not classified | #1028470 |
Documents (25)
- 483 · Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center · March 8, 2017
- WARNING LETTER · Cipla Limited · February 17, 2023
- 483 · New Era Pharmacy, LLC · November 27, 2019
- 483 · Oregon Compounding Centers, Inc. · August 28, 2014
- 483 · Shiraz Specialty Pharmacy, Inc. dba Axis Pharmacy Northwest · June 15, 2017
- WARNING LETTER · Aspen Pharmacare Holdings Limited · September 17, 2024
- 483 RESPONSE · Oregon Compounding Centers, Inc. · August 5, 2014
- EIR · AGC Biologics, Inc. · May 15, 2015
- 483 · Boehringer Ingelheim Fremont, Inc. · August 24, 2018
- EIR · OSO Biopharmaceuticals Manufacturing LLC · March 15, 2019
- EIR · Nitto Avecia Pharma Services, Inc. · May 24, 2019
- 483 · Oxarc, LLC · August 23, 2019
- 483 · C.P.M. Contract Pharma GmbH & Co. KG · July 5, 2019
- 483 · Eurofins Biopharma Product Testing Munich GmbH · July 12, 2019
- EIR · Genentech, Inc. · April 15, 2016
- 483 · Cardinal Health 414, Inc. · January 25, 2018
- EIR · Lonza Bend Inc · June 3, 2016
- 483 · Bakelite Chemicals LLC · November 20, 2019
- EIR · Pacira Pharmaceuticals, Inc. · March 1, 2018
- EIR · Curia New Mexico, LLC · March 15, 2019
- 483 · Amgen, Inc.
- 483 · Cardinal Health 414, Inc. · February 25, 2020
- 483 · Dendreon Corporation · November 2, 2018
- 483 · Herbal Doctor Remedies · April 19, 2019
- 483 · HF Acquisition Co LLC · February 9, 2018
Frequently inspected with (10)
Andrew K. Haack
Compliance Officer
2 shared
Christopher D. Leach
Compliance Officer at FDA
2 shared
Michael E. Maselli
investigator
2 shared
Allison A. Rodriguez
Investigator
1 shared
Annette L Diggs
1 shared
Bo Chi
1 shared
Diane R. Weidley
1 shared
Eileen A. Liu
1 shared
Felicia M. Orlando
investigator
1 shared
Joey V. Quitania
Public Affairs Specialist
1 shared
Person Information
Name
Anita Narula
Title
Compliance Officer - CDER/OC/OMQ
Role
Regulatory Personnel
ID: fbebf5a2-e25c-4e98-9c22-433d9102380c
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