FDA Person
Office of Regulatory AffairsMindy M. Chou
View detailed information about Mindy M. Chou, including compliance records, violations, and related data.
Person Profile
FDA investigator, Office of Regulatory Affairs. Took part in 66 inspections of 60 companies, 2016–2026.
Inspections (66)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 3, 2026 | OPS International Inc | Not classified | Drug Quality Assurance | #1332156 |
| July 29, 2026 | Renaissance Lakewood, LLC | Not classified | Drug Quality Assurance | #1327338 |
| May 14, 2026 | Fresenius Kabi USA, LLC | Not classified | Drug Quality Assurance | #1317954 |
| March 31, 2026 | Professional Disposables International, Inc. | Not classified | Drug Quality Assurance | #1310208 |
| February 5, 2026 | ONY Biotech, Inc. | Not classified | Drug Quality Assurance | #1301388 |
| January 14, 2026 | US Specialty Formulations LLC | Not classified | Drug Quality Assurance | #1298396 |
| November 18, 2025 | Chartwell Pharmaceuticals LLC | OAI | Drug Quality Assurance | #1277530 |
| September 2, 2025 | Kreitchman PET Center | Not classified | Drug Quality Assurance | #1280723 |
| August 22, 2025 | Vertice Pharma Management Corp | NAI | Drug Quality Assurance | #1285782 |
| August 14, 2025 | Janssen Pharmaceuticals, Inc | Not classified | #1271223 | |
| August 7, 2025 | Ruspak Corporation | VAI | Drug Quality Assurance | #1277819 |
| July 30, 2025 | Bausch & Lomb Incorporated | NAI | Drug Quality Assurance | #1282260 |
| July 24, 2025 | Arch Chemicals, Inc. | Not classified | #1277026 | |
| May 30, 2025 | MSD International GmbH (Singapore Branch) | NAI | Drug Quality Assurance | #1275234 |
| May 23, 2025 | Borden Company (Pte) Ltd | VAI | Drug Quality Assurance | #1270553 |
| May 16, 2025 | Symbiotica Speciality Ingredients, Sdn. Bhd. | Not classified | #1269554 | |
| January 23, 2025 | A.P. Deauville, LLC | OAI | Drug Quality Assurance | #1257678 |
| December 13, 2024 | Genus Lifesciences Inc. | Not classified | #1256528 | |
| September 6, 2024 | Unither Manufacturing LLC. | Not classified | Drug Quality Assurance | #1247547 |
| June 11, 2024 | GEN ILAC VE SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI FABRIKA SUBESI | OAI | Generic Drug Evaluation | #1240829 |
Documents (66)
- 483 · US Specialty Formulations LLC
- 483 · Pine Pharmaceuticals, LLC · May 14, 2021
- 483 · Compounded Solutions in Pharmacy, LLC · July 27, 2021
- 483 · Boothwyn Pharmacy LLC · June 16, 2017
- 483 · Healthy Choice Compounding LLC · September 24, 2020
- 483 · Kings Park Slope Inc · April 22, 2016
- 483 · William R. Grace M.D. P.C. · July 8, 2016
- 483 · Magellan Rx Pharmacy, LLC · December 22, 2016
- 483 · Pine Pharmaceuticals, LLC · October 9, 2015
- EIR · NCM USA LLC · December 8, 2017
- EIR · Berkshire Sterile Manufacturing, LLC · October 15, 2021
- EIR · Chartwell Pharmaceuticals Carmel LLC · December 16, 2019
- EIR · InvaGen Pharmaceuticals, Inc. · May 26, 2017
- EIR · InvaGen Pharmaceuticals, Inc. · March 13, 2012
- EIR · Patheon Biologics LLC · November 10, 2023
- EIR · Genus Lifesciences Inc. · December 13, 2024
- 483 · Kreitchman PET Center · September 2, 2025
- 483 · A.P. Deauville, LLC · January 23, 2025
- 483 · Catalent Maryland, Inc. · November 4, 2019
- 483 · Delsam Pharma LLC · March 24, 2023
- 483 · Zennova LLC · January 27, 2022
- 483 · Regeneron Pharmaceuticals Inc · October 18, 2019
- EIR · Cerovene Inc. · February 8, 2017
- EIR · Chartwell Pharmaceuticals Carmel LLC · November 2, 2015
- EIR · Catalent Maryland, Inc. · November 4, 2019
- EIR · Aphena Pharma Solutions-Maryland LLC · December 15, 2021
- 483 · Ruspak Corporation · August 7, 2025
- 483 · United Therapeutics Corporation · May 2, 2024
- EIR · AMA Laboratories, Inc. · November 17, 2016
- 483 · Akorn Operating Company LLC · May 17, 2022
- 483 · Perrigo New York, Inc. · January 22, 2019
- 483 · Reliant Compounded Solutions Monroe, LLC · July 27, 2021
- 483 · Sciegen Pharmaceuticals Inc · September 2, 2022
- 483 · Cosmetica Laboratories Inc. · June 1, 2018
- 483 · Precision Nuclear of Virginia · March 25, 2022
- 483 · Holopack Verpackungstechnik GmbH · February 18, 2020
- 483 · Arch Chemicals, Inc.
- 483 · Strides Pharma, Inc. · June 4, 2015
- EIR · Advanced Accelerator Applications USA, Inc. · November 3, 2022
- 483 · BASF Corporation · November 17, 2017
- 483 · Norwich Pharmaceuticals, Inc. · March 16, 2021
- 483 · RK Pharma Inc. · August 12, 2022
- 483 · Patheon Italia S.p.A. · May 26, 2023
- 483 · Diora Kimya Sanayi ve Ticaret Limited Sirketi · May 31, 2024
- 483 · Advanced Accelerator Applications USA, Inc. · November 3, 2022
- 483 · Professional Disposables International, Inc. · May 28, 2019
- 483 · Hercon Pharmaceuticals, LLC · April 5, 2019
- 483 · Genus Lifesciences Inc. · December 13, 2024
- EIR · Fresenius Kabi USA, LLC · March 30, 2017
- 483 · Healthy Choice Compounding LLC · February 28, 2017
- 483 · Steri-Pharma, LLC · October 4, 2022
- 483 · Chartwell Pharmaceuticals Carmel LLC · December 16, 2019
- 483 · Park Avenue Compounding · August 28, 2019
- 483 · Sofie Co dba Sofie · December 3, 2018
- 483 · J.M. Murray Center, Inc. · April 30, 2021
- 483 · Fresenius Kabi USA, LLC · October 13, 2023
- EIR · Regeneron Pharmaceuticals Inc · October 18, 2019
- 483 · NCM USA LLC · December 8, 2017
- 483 · Aphena Pharma Solutions-Maryland LLC · December 15, 2021
- 483 · Berkshire Sterile Manufacturing, LLC · October 15, 2021
- 483 · A.P. Deauville, LLC · December 15, 2023
- 483 · ONY Biotech, Inc. · February 5, 2026
- 483 · Fresenius Kabi USA, LLC · May 14, 2026
- EIR · Delsam Pharma LLC · March 24, 2023
- 483 · OPS International Inc · September 3, 2026
- 483 · Renaissance Lakewood, LLC · July 29, 2026
Frequently inspected with (10)
Alice S. Tsao
Consumer Safety Officer at FDA
4 shared
Philip F. Istafanos
3 shared
Rachael A. Moss
3 shared
Brandy N. Lepage
Consumer Safety Officer
2 shared
Emmanuel T. Donyina
2 shared
Janet A. Rajan
Investigator
2 shared
Lauren H. Augustyniak
2 shared
Lu Chen
Investigator
2 shared
Alisha B. Patel
1 shared
Annet R. Rajan
1 shared
Related Office
Person Information
Name
Mindy M. Chou
Role
Regulatory Personnel
ID: 3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5
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.