Recently Requested BIMO 483s
For a list of 483s FDAnews has requested, click here.
March 2023 |
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District | Inspection Date | Firm Name |
CIN-DO | 3/1/2023 | Michael J Rosen MD |
FLA-DO | 3/3/2023 | Tory P. Sullivan, M.D., P.A. |
MIN-DO | 3/3/2023 | John C. Lieske, M.D., Clinical Investigator |
NYK-DO | 3/3/2023 | Mrinal M. Gounder, M.D. |
BLT-DO | 3/6/2023 | Howard M. Richard, III M.D. |
BLT-DO | 3/6/2023 | Reveragen Biopharma Inc. |
CHI-DO | 3/10/2023 | Experimur, A Frontage Company |
DAL-DO | 3/10/2023 | Joseph C Gathe, Jr, MD, CI |
DEN-DO | 3/10/2023 | Nicola Longo, M.D., Ph.D. |
FLA-DO | 3/10/2023 | Rosa M. Suarez, M.D. |
NWE-DO | 3/10/2023 | Glenn Gandelman, M.D. |
NWE-DO | 3/10/2023 | Maryellen Fitzgerald, M.D. |
NWJ-DO | 3/14/2023 | Ferring Pharmaceuticals Inc |
CDER | 3/17/2023 | Sun Pharmaceutical Industries Limited |
DAL-DO | 3/17/2023 | Kathleen N. Moore, M.D. |
NYK-DO | 3/17/2023 | Richard W. Foltin, Ph.D. |
DAL-DO | 3/23/2023 | Brian Flowers |
BLT-DO | 3/24/2023 | H. Henry Li, MD |
DAL-DO | 3/24/2023 | Edward Fox, M.D. |
LOS-DO | 3/30/2023 | Fred K. Kurata, M.D. |
ATL-DO | 3/31/2023 | SpringWorks Therapeutics, Inc. |
CDER | 3/31/2023 | KRM Hospital and Research Centre |
CDER | 3/31/2023 | Jatin Vadhvana, M.B.B.S. |
February 2023 |
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District | Inspection Date | Firm Name |
NYK-DO | 2/2/2023 | N.Y.S. Psychiatric Institute IRB |
MIN-DO | 2/3/2023 | Children's Healthcare IRB #1 |
NWE-DO | 2/3/2023 | Francine M. Foss |
FLA-DO | 2/6/2023 | Scott H. Schecter, O.D. |
CDER | 2/10/2023 | P.D.E.A.'s Ayurved Rugnalaya & Sterling Multispeciality Hospital |
CDER | 2/10/2023 | Divyam Institute of Psychiatry, dba Divyam Hospital |
LOS-DO | 2/10/2023 | Immunity Bio, Inc |
LOS-DO | 2/10/2023 | Dante Pieramici, M.D. |
NWJ-DO | 2/10/2023 | AtlantiCare Regional Medical Center IRB |
SAN-DO | 2/13/2023 | Kent L. Wellish, M.D. |
LOS-DO | 2/15/2023 | Merrill K. Shum, M.D. |
DEN-DO | 2/16/2023 | Cameron G. Javid, M.D. |
DAL-DO | 2/17/2023 | Scott R. Bartley, M.D. |
FLA-DO | 2/17/2023 | E5 Pharma LLC |
FLA-DO | 2/17/2023 | Manuel F. Fernandez, M.D. |
SJN-DO | 2/17/2023 | Jorge L. Martinez Trabal, MD |
LOS-DO | 2/24/2023 | Donald M Brandon MD |
SJN-DO | 2/24/2023 | Ponce Medical School Foundation, Inc. IRB |
DEN-DO | 2/27/2023 | Redbeast Enterprises Inc dba High Quality Research |
January 2023 |
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District | Inspection Date | Firm Name |
NYK-DO | 1/10/2023 | Bret R. Rutherford, M.D. |
CIN-DO | 1/13/2023 | Steven D. Folkerth, M.D. |
DAL-DO | 1/13/2023 | Madeleine Duvic, M.D. |
DEN-DO | 1/13/2023 | Sri Sundaram, M.D. |
KAN-DO | 1/13/2023 | Kathleen Jones, M.D., Clinical Investigator |
NWE-DO | 1/13/2023 | AxioMed, LLC. |
NWJ-DO | 1/19/2023 | ACROTECH BIOPHARMA, Inc |
CDER | 1/20/2023 | ZenRise Clinical Research Pvt., Ltd |
CDRH | 1/20/2023 | Garen Koloyan, M.D., PhD. |
DET-DO | 1/20/2023 | Reproductive Services Of Indiana, Inc |
FLA-DO | 1/23/2023 | Luis Pena-Hernandez, M.D. |
DAL-DO | 1/26/2023 | Sloan W. Rush, M.D. |
DET-DO | 1/27/2023 | Robert M. Pascuzzi, M.D. |
FLA-DO | 1/27/2023 | ECI Pharmaceuticals, LLC |
FLA-DO | 1/27/2023 | Kwabena (NMI) Ayesu, M.D. |
FLA-DO | 1/27/2023 | Banji Awosika, M.D. |
FLA-DO | 1/30/2023 | Antonio E. Blanco, M.D. |
BLT-DO | 1/31/2023 | Sharleen St. Surin-Lord, M.D. |