Eir Records
Browse through 558 eir records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.
Showing 20 of 558 records
Oklahoma Blood Institute - IRB
Product: Biologics
Office: Dallas District Office
People: Margaret M. Annes
Violations: 5 code(s)
Linda D. Bosserman
Product: Drugs
Office: Los Angeles District Office
People: Linda D. Bosserman, Carla J. Lundi (Senior Consumer Safety Officer)
Violations: 3 code(s)
Alliance Medical Products, Inc. DBA Siegfried Company
Product: Drugs
Office: Los Angeles District Office
People: Kim L. Thomas Cruse (Chemit), Teresa T. Cain (investigator), Carla J. Lundi (Senior Consumer Safety Officer)
Violations: 1 code(s)
Alliance Medical Products, Inc. DBA Siegfried Company
Product: Drugs
Office: Los Angeles District Office
Violations: 5 code(s)
Richard De La Garza, II, Ph.D
Product: Drugs
Office: Dallas District Office
People: Andrea A. Branche (CSO), Richard De La Garza, II, Ph.D
Violations: 4 code(s)
AGILENT TECHNOLOGIES INC./US
Product: drugs
Office: Division of Pharmaceutical Quality Operations I
People: Erika V. Butler (Compliance Officer / Investigator)
Solara Active Pharma Sciences Limited
Product: drugs
Office: Office of Regulatory Affairs
People: Kham Phommachanh (Investigator), Karen G. Sego (other), Kevin A. Gonzalez (Branch Chief, Foreign Pharmaceutical Quality Inspection at FDA)
Violations: 1 code(s)
Ashley S. Plant, M.D.
Product: drugs
Office: Cincinnati District Office
People: Ashley L. Devonshire (recipient), Justin Schwartz (company_representative), Nichole Kamos (company_representative)
Violations: 5 code(s)
Boehringer Ingelheim Pharmaceuticals, Inc.
Product: drugs
Office: Center for Drug Evaluation and Research
People: Michelle M. Noe (investigator), M. Patricia Murphy (investigator), Sharon K. Gershon (investigator)
Violations: 3 code(s)
Andre Kalil, M.D.
Product: drugs
Office: Center for Drug Evaluation and Research
People: Andre C. Kalil (recipient), Courtney R. Bratina (issuing_officer), LuAnn R. Larson (company_representative)
Violations: 5 code(s)
Pharmaceutics International Inc
Product: drugs
Office: Center for Drug Evaluation and Research
People: Bijoy Panicher (investigator), Christina K. Theodorou (Consumer Safety Officer), Kristina L. Conroy (Investigator)
Violations: 5 code(s)
PharmaZell GmbH
Product: drugs
Office: Center for Drug Evaluation and Research
People: Concepcion Cruz (FDA Alumnus, Principal at ESCODA Consulting Group, and Scientific Advisory Board Member at AiZen Algo), Valerie L. Whipp (issuing_officer), Deyaa Shaheen (Drug Investigator)
Violations: 1 code(s)
Medtronic MiniMed, Inc.
Product: devices
Office: Office of Medical Device and Radiological Health Operations, Division 3 – West
People: Matthew M. Vernon (investigator), Steven R. Souza (investigator), Elizabeth A. Dakan (investigator)
Violations: 5 code(s)
Brooks Life Sciences
Product: biologics
Office: Los Angeles District Office
People: Comyar Shoghi (investigator), Nelson P. Lopez (recipient), Michael Lebbin (company_representative)
Brooks Life Sciences
Product: biologics
Office: Los Angeles District Office
People: Michael Lebbin (company_representative), Nelson P. Lopez (recipient), Jason Turk (company_representative)
Violations: 2 code(s)
Catalent Belgium SA
Product: drugs
Office: Center for Drug Evaluation and Research
People: Yasamin Ameri (Compliance Officer), Atul J. Agrawal (Regulatory Affairs), Michael R. Klapal (Investigator)
Violations: 1 code(s)
ICON Laboratory Services, Inc.
Product: biologics
Office: Center for Drug Evaluation and Research
People: Seonguen Julia Cho (issuing_officer), Kara A. Scheibner (issuing_officer), Mario L. Rocci Jr (company_representative)
Lonza AG
Product: drugs
Office: Center for Drug Evaluation and Research
People: Jose Martinez (issuing_officer), Santos E. Camara
Draco Natural Products, Inc.
Product: Food
Office: Center for Food Safety and Applied Nutrition
People: David A. Quale (investigator), James Chen (company_representative), Jerry Wu (company_representative)
Violations: 2 code(s)
Eli Lilly And Company
Product: drugs
Office: Center for Drug Evaluation and Research
People: Cara L. Alfaro (other), Eric S. Myskowski (issuing_officer), Karen M. Montgomery (issuing_officer)
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