FDA Person
FDAMizanne E. Lewis
View detailed information about Mizanne E. Lewis, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 126 inspections of 97 companies, 2016–2026.
Inspections (126)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 22, 2026 | Reproductive Medicine Associates of Florida | NAI | Human Cellular, Tissue, and Gene Therapies | #1337896 |
| August 20, 2026 | OurLegacy Organ & Tissue Donation Services | Not classified | Human Cellular, Tissue, and Gene Therapies | #1331798 |
| August 14, 2026 | Celquest LLC | Not classified | #1295462 | |
| July 14, 2026 | Regenerative Biologics, Inc. | NAI | Human Cellular, Tissue, and Gene Therapies | #1327366 |
| June 10, 2026 | Cord for Life, Inc. | Not classified | Human Cellular, Tissue, and Gene Therapies | #1321378 |
| May 7, 2026 | Brown Fertility Associates P.A. | Not classified | #1318412 | |
| April 23, 2026 | Grifols Bio Supplies Inc | NAI | Blood and Blood Products | #1314386 |
| April 3, 2026 | KweHealth LLC | Not classified | Human Cellular, Tissue, and Gene Therapies | #1292494 |
| March 26, 2026 | OneBlood, Inc. | Not classified | Blood and Blood Products | #1309376 |
| February 26, 2026 | Biograft Transplant Services Inc | Not classified | #1307000 | |
| February 20, 2026 | MD Anderson Cord Blood Bank | NAI | Human Cellular, Tissue, and Gene Therapies | #1305506 |
| January 30, 2026 | RTI Surgical, Inc. dba RTI Biologics, Inc. | Not classified | Human Cellular, Tissue, and Gene Therapies | #1284376 |
| December 17, 2025 | OneBlood, Inc. | NAI | Blood and Blood Products | #1297638 |
| November 21, 2025 | BioLife Plasma Services LP | NAI | Blood and Blood Products | #1293944 |
| November 21, 2025 | BioLife Plasma Services LP | Not classified | #1293944 | |
| October 10, 2025 | Biomat USA, Inc. | Not classified | #1285720 | |
| August 7, 2025 | U.S. Navy Medicine Readiness and Training Command Rota Spain | Not classified | #1279065 | |
| August 4, 2025 | Dept. of the Air Force - 48th Medical Group/SGSAL | Not classified | #1279682 | |
| August 1, 2025 | Roche Diagnostics GmbH | Not classified | Blood and Blood Products | #1277484 |
| July 25, 2025 | Fresenius Kabi Horatev CZ s.r.o. | Not classified | #1279405 |
Documents (16)
- 483 · Cord for Life, Inc. · August 26, 2021
- 483 · Roche Diagnostics GmbH · August 1, 2025
- EIR · Synexus Clinical Research US, Inc. · February 5, 2014
- 483 · BioTissue Holdings Inc · July 16, 2019
- EIR · Octapharma Plasma, Inc. · October 24, 2019
- 483 · Vetter Pharma Fertigung GmbH & Co. KG · May 13, 2019
- 483 · Neobiosis LLC · February 21, 2023
- 483 · Dept. of the Army - Armed Services Blood Bank Ctr. - Europe · August 23, 2023
- 483 · CoreRX Inc. · January 24, 2014
- 483 · Lux Therapeutics LLC · June 6, 2025
- 483 · Lux Therapeutics LLC · May 12, 2023
- 483 · RTI Surgical, Inc. dba RTI Biologics, Inc. · January 30, 2026
- 483 · Biograft Transplant Services Inc · February 26, 2026
- 483 · OneBlood, Inc. · March 26, 2026
- 483 · KweHealth LLC · April 3, 2026
- 483 · Cord for Life, Inc. · June 10, 2026
Frequently inspected with (10)
Steen N. Graham
9 shared
Lura D. Kelly
6 shared
Cody D. Rickman
5 shared
Barbara T. Carmichael
Investigator at U.S.FDA
4 shared
Prabhu P. Raju
Program Expert for Advanced Manufacturing
2 shared
Scott T. Ballard
2 shared
Abby L. Mozeke
1 shared
Annette Melendez
1 shared
Ashleigh M. Robertson
1 shared
Dianiris C. Ayala
1 shared
Person Information
Name
Mizanne E. Lewis
Title
investigator
Role
COMPANY REP
ID: c79964ac-5163-44a2-89e9-8cc8775de9b4
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