Response Records
Browse through 136 response records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.
Showing 20 of 136 records
Cosway Company, Inc.
Product: OTC (Over-the-Counter)
Office: Office of Regulatory Affairs
People: Steven E. Porter (Program Division Director), Sara H. Gabel, Kenneth O. Gee (Consumer Safety Officer)
Agility Medical Research, Inc.
Product: Other
Office: Office of Bioresearch Monitoring Inspectorate
People: Richard A. Lyght
Cosway Company, Inc.
People: Amanda Lai (company_representative)
Catalent Massachusetts, LLC
Office: Division of Pharmaceutical Quality Operations I
People: Sarah McLaughlin (company_representative), Gordon Ashton (recipient)
Violations: 1 code(s)
N-Molecular Inc. d.b.a. SOFIE
Product: Veterinary
People: Sean R. Marcsisin (Senior Consumer Safety Officer - Pharmaceutical Quality), William Crisp, Lori M. Newman (Deputy Director)
Life Science Pharmacy Inc
Product: Drugs
Office: Office of Pharmaceutical Quality
People: Diana Amador-Toro (District Director), Scott Berliner, Diane Amador-toro (Ms.)
Violations: 2 code(s)
Abbott Medical
Product: Devices
Office: Office of Health Technology 5 (Neurological and Physical Medicine Devices)
People: Philip Tsung, Alonza E. Cruse (Director)
Violations: 4 code(s)
Eli Lilly & Company
Product: Devices
Office: Center for Devices and Radiological Health
People: Hung V. Le (Investigator), Judith A. Putz (Ms.), Jeffrey Sommers
Violations: 5 code(s)
IV Solutions of Lubbock
Product: Devices
Office: Office of Health Technology 2 (Cardiovascular Devices)
People: Michael J. Donovan (Writer), Ricky Rodriguez (Mr.), James C. Illuminati (Executive Director)
Violations: 5 code(s)
Invacare Corporation
Product: Devices
Office: Center for Devices and Radiological Health
People: Ronald J. Clines, Tina C. Kelm (Deputy Office Director), Jeffrey P. Raimondi (Consumer Safety Officer)
Violations: 5 code(s)
Invacare Corporation
Product: Devices
Office: Center for Devices and Radiological Health
People: Ronald J. Clines, Gera Ld B. Blouch, Tina C. Kelm (Deputy Office Director)
Violations: 5 code(s)
Invacare Corporation
Product: Devices
Office: Center for Devices and Radiological Health
People: Ronald J. Clines, Gera Ld B. Blouch, Tina C. Kelm (Deputy Office Director)
Violations: 5 code(s)
Invacare Corporation
Product: Devices
Office: Center for Devices and Radiological Health
People: Jolanna A. (Medical Content Writer), Gera Ld B. Blouch, Ronnie E. Jackson (Retired Former Director of Compliance)
Violations: 1 code(s)
Invacare Corporation
Product: Devices
Office: Center for Devices and Radiological Health
People: Ronald J. Clines, Gera Ld B. Blouch, Tina C. Kelm (Deputy Office Director)
Violations: 3 code(s)
Invacare Corporation
Office: Department of Health and Human Services
People: Jolanna A. (Medical Content Writer), Gera Ld B. Blouch, Ronnie E. Jackson (Retired Former Director of Compliance)
Product: Devices
Office: Office of Health Technology 5 (Neurological and Physical Medicine Devices)
People: Ann Simoneau (Director), Marcellinus D. Dordunoo (Investigator), Barry J. Cadden (Mr.)
Violations: 2 code(s)
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