FDA Person
Office of the CommissionerLucas B. Leake
View detailed information about Lucas B. Leake, including compliance records, violations, and related data.
Person Profile
FDA investigator, Office of the Commissioner. Took part in 22 inspections of 22 companies, 2016–2018.
Inspections (22)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| March 22, 2018 | Alivus Life Sciences Limited | Not classified | #1047179 | |
| March 16, 2018 | Vamsi Labs Ltd | VAI | Drug Quality Assurance | #1046688 |
| January 16, 2018 | Biospring Gmbh | NAI | Drug Quality Assurance | #1042485 |
| January 12, 2018 | Serumwerk Bernburg AG | VAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1040866 |
| November 17, 2017 | Savior Lifetec Corporation, Tainan Branch Injection Plant | NAI | Drug Quality Assurance | #1034113 |
| November 7, 2017 | Takeda Pharmaceutical Company Limited | NAI | Drug Quality Assurance | #1033814 |
| September 28, 2017 | Ultra Mix (Aust) Pty Ltd | VAI | Drug Quality Assurance | #1027817 |
| September 22, 2017 | Baxter Laboratories Pty. Ltd. | VAI | Drug Quality Assurance | #1027816 |
| September 15, 2017 | Alphapharm Pty, Ltd. | NAI | Drug Quality Assurance | #1029077 |
| July 28, 2017 | Sintenovo SA de CV | Not classified | #1024128 | |
| July 20, 2017 | Industrias Quimicas Falcon de Mexico, SA de CV (Dr. Reddy's Mexico) | Not classified | #1022674 | |
| June 1, 2017 | NerPharMa S.r.l. | VAI | Drug Quality Assurance | #1017090 |
| May 23, 2017 | Astellas Ireland Co Ltd | NAI | Drug Quality Assurance | #1016874 |
| April 7, 2017 | Zydus Lifesciences Limited | Not classified | #1010025 | |
| March 31, 2017 | Sidmak Laboratories India Pvt Ltd | VAI | Drug Quality Assurance | #1009631 |
| March 23, 2017 | Jubilant Generics Limited | NAI | Drug Quality Assurance | #1007262 |
| February 3, 2017 | Sella Natural Cosmetics Co., Ltd. | VAI | Drug Quality Assurance | #1005503 |
| January 26, 2017 | JW Bio Co., Ltd. | OAI | Drug Quality Assurance | #1004937 |
| January 20, 2017 | Tai Guk Pharm Co., Ltd., Buyeo branch | VAI | Drug Quality Assurance | #1004935 |
| November 15, 2016 | Taejoon Pharmaceutical Co., Ltd. | VAI | Drug Quality Assurance | #994512 |
Documents (11)
- 483 · Oakdell Pharmacy, LLC · March 1, 2013
- 483 · Specialty Compounding, LLC · September 13, 2013
- 483 · Home Intensive Care Pharmacy, Inc. · March 1, 2013
- 483 · ASP Cares · July 23, 2015
- 483 · I.V. Specialty, Ltd · July 17, 2014
- 483 · ICU Medical Inc · August 24, 2012
- 483 · Specialty Compounding, LLC · March 22, 2013
- EIR · Industrias Quimicas Falcon de Mexico, SA de CV (Dr. Reddy's Mexico) · July 20, 2017
- 483 · Hetero Labs Limited - Unit III · July 31, 2015
- EIR · Mission Pharmacal Company · February 7, 2014
- 483 · Mission Pharmacal Company · February 7, 2014
Frequently inspected with (1)
Dinesh Kumar
1 shared
Related Office
Person Information
Name
Lucas B. Leake
Title
Investigator
Role
Regulatory Personnel
ID: f4c191d4-25d1-4eb8-8dc9-4d1aa483a441
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.