Richard W. Berning
View detailed information about Richard W. Berning, including compliance records, violations, and related data.
Person Profile
FDA investigator, Center for Biologics Evaluation and Research. Took part in 98 inspections of 96 companies, 2016–2026.
Inspections (98)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 18, 2026 | Prof. Dr. Eduardo M. Rego | Not classified | #1340026 | |
| September 11, 2026 | Monica Maria Gomes da Silva, MD, PhD | Not classified | #1335972 | |
| July 24, 2026 | Dr. W. Edward Visser | Not classified | #1332746 | |
| July 24, 2026 | Erasmus University Medical Center | Not classified | #1332548 | |
| July 17, 2026 | Median Technologies | Not classified | #1331444 | |
| May 22, 2026 | Valeria Caceres, M.D., Ph.D. | Not classified | #1322278 | |
| May 18, 2026 | Margarita Alfie, MD | Not classified | #1322030 | |
| May 11, 2026 | Dr. Miguel Hominal | Not classified | #1319004 | |
| March 20, 2026 | Abbisko Therapeutics Co., Ltd. | Not classified | Bioresearch Monitoring: Human Drugs | #1310500 |
| March 6, 2026 | Prof. Xiaohui Niu | Not classified | #1310546 | |
| January 29, 2026 | Bernardo Leon Rapoport, M.D. | VAI | Bioresearch Monitoring: Human Drugs | #1300998 |
| December 12, 2025 | Dr. Vanda Salutari | NAI | Bioresearch Monitoring | #1299038 |
| December 5, 2025 | Prof. Nicoletta Colombo, M.D. | Not classified | #1298678 | |
| November 12, 2025 | Jason A. Ohayon, MD | Not classified | #1295674 | |
| November 7, 2025 | Gideon Hirschfield, M.D. | NAI | Bioresearch Monitoring | #1291770 |
| September 19, 2025 | Rosie Mngqibisa | NAI | Bioresearch Monitoring | #1287152 |
| September 12, 2025 | Lesley J. Burgess, MB. Ch. B., M. Med., Ph. D. | NAI | Bioresearch Monitoring | #1285324 |
| September 5, 2025 | Sinead Delany-Moretlwe, MBBCH, PhD, DTM&H | NAI | Bioresearch Monitoring | #1286336 |
| July 24, 2025 | Biotech, Inc. | NAI | Bioresearch Monitoring | #1289106 |
| July 24, 2025 | Shanghai Henlius Biotech, Inc. | Not classified | #1289106 |
Documents (18)
- 483 · Prof. Dimitar Shishkov, MD · December 12, 2024
- 483 · Petar Bilic, MD, PhD · March 21, 2025
- 483 · Dr. Pablo Forte Soto MD, MSc, DPhil · May 2, 2025
- 483 · Savita Rangarajan, MD, MBBS, FRCPath · September 27, 2024
- 483 · Dean L. Harris · May 5, 2023
- 483 · Prof. Marek Hus · May 9, 2025
- EIR · PATH · April 1, 2016
- 483 · Sun Pharmaceutical Industries Limited · March 17, 2023
- 483 · Prof. Thomas Zeller, M.D. · May 25, 2018
- EIR · Ming-Shen Dai, M.D., Ph.D. · September 27, 2019
- 483 · Jason A. Ohayon, MD · November 12, 2025
- EIR · Frontage Laboratories, Inc. · September 23, 2016
- 483 · Ming-Shen Dai, M.D., Ph.D. · September 27, 2019
- 483 · PAREXEL International GmbH · August 18, 2016
- 483 · Frontage Laboratories, Inc. · September 23, 2016
- 483 · Bernardo Leon Rapoport, M.D. · January 29, 2026
- 483 · Abbisko Therapeutics Co., Ltd. · March 20, 2026
- EIR · David J. Johnson, M.D. · July 13, 2018
Frequently inspected with (10)
Kathryn Suttling
3 shared
Lakecha N. Lewis
Business Analyst/Provider Enrollment Specialist
3 shared
Tawny L. Colling
investigator
3 shared
Lori Gioia
Investigator
2 shared
Angelica M. Chica
1 shared
Anna M. Brannen
1 shared
Cynthia F. Kleppinger
1 shared
Farwa Z. Razvi
issuing_officer
1 shared
Jennifer C. Adams
issuing_officer
1 shared
Jenn W. Sellers
1 shared
Related Office
Person Information
Name
Richard W. Berning
Title
Bioresearch Monitoring Foreign Inspection Cadre Member
Role
INVESTIGATOR
ID: 4637e321-8803-4fcf-911f-bbc810c3487d
Get More Insights
Access our comprehensive quality intelligence platform to analyze patterns, track compliance trends, and stay ahead of regulatory changes.
1.5M+ regulatory data points
Real-time compliance monitoring
Interactive analytics dashboard
Looking for more people? Our platform provides access to thousands of FDA people with advanced search and filtering capabilities.
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.