Warning Letter Response Records
Browse through 17 warning letter response records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.
Showing 17 of 17 records
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)
McNeil Healthcare, LLC
Product: Devices
Office: Center for Devices and Radiological Health
People: Sam Jiwrajka, Peter Luther, Adaliz Santaliz-Cruz
Violations: 4 code(s)
Product: Devices
Office: Center for Devices and Radiological Health
People: Bruce R. Ota (Compliance Officer), Barry J. Cadden (Mr.)
Violations: 5 code(s)
Revival Products Inc
Product: Devices
Office: Office of Health Technology 5 (Neurological and Physical Medicine Devices)
People: Patricia F. Hudson, Suzanne Tabor
Randol Mill Pharmacy
Product: Drugs
Office: Office of Pharmaceutical Quality
People: Mark W. Rivero (Compliance Officer), Gary D. Daley
Wedgewood Village Pharmacy, LLC
Product: Drugs
Office: Office of Pharmaceutical Quality
People: Nerizza Guerin (Director of Investigations Branch), Marcy Bliss
Barclay, Luke, & Pillai Specialty Pharmacy, PLLC
Product: Drugs
Office: Division of Pharmaceutical Quality Operations I
People: Sean M. Barclay, Steven E. Porter (Program Division Director)
Triad Rx, Inc
Product: Drugs
Office: Office of Pharmaceutical Quality
People: Ronda Loyd-jones (Director of Compliance Branch), Matt Mcdonald
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