FDA Person
FDAJames M. Mason
View detailed information about James M. Mason, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 25 inspections of 24 companies, 2016–2025.
Inspections (25)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| June 12, 2025 | Troy Manufacturing, Inc. | Not classified | #1275066 | |
| June 7, 2023 | Bayer HealthCare LLC | NAI | Drug Quality Assurance | #1209567 |
| June 15, 2018 | Sanofi Vaccines US Inc. | NAI | Drug Quality Assurance | #1056859 |
| April 12, 2018 | Viatris Inc. | OAI | Generic Drug Evaluation | #1047915 |
| February 7, 2018 | David Dolezil | NAI | Bioresearch Monitoring | #1042476 |
| January 25, 2018 | Istvan Szikora, MD | NAI | Bioresearch Monitoring | #1042477 |
| December 19, 2017 | Accupac, Inc. | VAI | Drug Quality Assurance | #1035664 |
| November 16, 2017 | Pharmaceutics International Inc | VAI | Generic Drug Evaluation | #1031480 |
| November 2, 2017 | Accupac, LLC | VAI | Drug Quality Assurance | #1030873 |
| October 25, 2017 | Walter's Pharmacy, Inc. | Not classified | #1031881 | |
| September 8, 2017 | HK Kolmar USA LLC | NAI | Colors and Cosmetics Technology | #1031330 |
| August 29, 2017 | US Specialty Formulations LLC | OAI | Drug Quality Assurance | #1023411 |
| July 20, 2017 | Hayward Laboratories, Inc. | VAI | Drug Quality Assurance | #1019019 |
| June 15, 2017 | Cook's Pharmacy | NAI | Drug Quality Assurance | #1029802 |
| June 9, 2017 | Menasha Packaging Company, LLC | NAI | Drug Quality Assurance | #1016702 |
| May 25, 2017 | Pharmaceutical Manufacturing Research Services, Inc (PMRS) | Not classified | New Drug Evaluation | #1015444 |
| April 28, 2017 | Hercon Pharmaceuticals, LLC | Not classified | Drug Quality Assurance | #1012285 |
| March 30, 2017 | PAREXEL Bloemfontein Early Phase Clinical Unit | Not classified | #1006011 | |
| March 23, 2017 | Hendrik-Tobias Arkenau | NAI | Bioresearch Monitoring | #1007453 |
| February 28, 2017 | Royal Chemical Company | VAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1002301 |
Documents (23)
- 483 · Central Admixture Pharmacy Services, Inc. · September 19, 2016
- STATE REFERRAL LETTER · Lynnfield Drug, Inc. dba Freedom Fertility Pharmacy · February 16, 2018
- WARNING LETTER · US Pharmaceuticals Inc. · December 18, 2018
- WARNING LETTER · AllerQuest LLC · March 1, 2019
- 483 · US Specialty Formulations LLC · August 29, 2017
- 483 · Berkshire Layers · April 6, 2011
- 483 · US Specialty Formulations LLC · May 29, 2015
- 483 · Dorneyville Pharmacy · January 7, 2016
- 483 · Walter's Pharmacy, Inc. · March 1, 2016
- STATE REFERRAL LETTER · East Marietta Drug Company · August 21, 2019
- STATE REFERRAL LETTER · Keystone Rx LLC · July 8, 2019
- STATE REFERRAL LETTER · Insight Pharmacy · January 16, 2019
- STATE REFERRAL LETTER · PharmScript, LLC · July 30, 2018
- UNTITLED LETTER · Arnold Professional Pharmacy · September 5, 2018
- 483 · Viatris Inc. · April 12, 2018
- EIR · Pharmaceutical Manufacturing Research Services, Inc (PMRS) · May 25, 2017
- EIR · ScieGen Pharmaceuticals, Inc · April 20, 2018
- 483 · Pharmaceutics International Inc · November 16, 2017
- EIR · Copperhead Chemical Company, Inc. · April 24, 2023
- EIR · BioSpectra, Inc. · January 29, 2016
- EIR · Sharp Packaging Services, LLC · February 3, 2017
- 483 · Pharmaceutical Manufacturing Research Services, Inc (PMRS) · May 25, 2017
- 483 · Johnson & Johnson Consumer, Inc · March 27, 2015
Frequently inspected with (10)
Ko U. Min
Consumer Safety Officer at FDA U.S. Food and Drug Administration
3 shared
Christina K. Theodorou
Consumer Safety Officer
2 shared
David A. Oluwo
Pharmacy Intern/Certified Pharmacy Technician
2 shared
Marcus A. Ray
Supervisory Consumer Safety Officer, China Office
2 shared
Alison N. Stieg
Staff Director
1 shared
Amy N. Chen
Investigator
1 shared
Atul Agrawal
1 shared
Brian S. Keefer
Investigator at US Food and Drug Administration
1 shared
Cedar H. Korang-Yeboah
1 shared
Craig D. Zagata
Investigator
1 shared
Person Information
Name
James M. Mason
Role
ISSUING OFFICER
ID: a9f601a9-5d81-4386-90dc-80466edb5880
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