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: Alonza E. Cruse (Director), Philip Tsung
Violations: 4 code(s)
Eli Lilly & Company
Product: Devices
Office: Center for Devices and Radiological Health
People: Thomas J. (Regulatory Counsel), Judith A. Putz (Ms.), Hung V. Le (Investigator)
Violations: 5 code(s)
IV Solutions of Lubbock
Product: Devices
Office: Office of Health Technology 2 (Cardiovascular Devices)
People: Ricky Rodriguez (Mr.), Carl Birdsong, Michael J. Donovan (Writer)
Violations: 5 code(s)
Invacare Corporation
Product: Devices
Office: Center for Devices and Radiological Health
People: Ronnie E. Jackson (Retired Former Director of Compliance), Gerald Blouch, Tina C. Kelm (Deputy Office Director)
Violations: 5 code(s)
Invacare Corporation
Product: Devices
Office: Center for Devices and Radiological Health
People: Gera Ld Blouch, Ronnie E. Jackson (Retired Former Director of Compliance), Gerald Blouch
Violations: 5 code(s)
Invacare Corporation
Product: Devices
Office: Center for Devices and Radiological Health
People: Gera Ld Blouch, Ronnie E. Jackson (Retired Former Director of Compliance), L ind a Baker
Violations: 5 code(s)
Invacare Corporation
Product: Devices
Office: Center for Devices and Radiological Health
People: Gera Ld Blouch, Ronnie E. Jackson (Retired Former Director of Compliance), Salvatore N. Randazzo (Consumer Safety Officer)
Violations: 1 code(s)
Invacare Corporation
Product: Devices
Office: Center for Devices and Radiological Health
People: Gera Ld Blouch, Ronnie E. Jackson (Retired Former Director of Compliance), Gerald Blouch
Violations: 3 code(s)
Invacare Corporation
Office: Department of Health and Human Services
People: Salvatore N. Randazzo (Consumer Safety Officer), Gera Ld Blouch, Ronnie E. Jackson (Retired Former Director of Compliance)
Record 79cabcf3
Product: Devices
Office: Office of Health Technology 5 (Neurological and Physical Medicine Devices)
People: Ann Simoneau (Director), Barry J. Cadden (Mr.), Marcellinus D. Dordunoo (Investigator)
Violations: 2 code(s)
McNeil Healthcare, LLC
Product: Devices
Office: Center for Devices and Radiological Health
People: Margarita Santiago (Consumer Safety Officer), Adaliz Santaliz-Cruz, Peter Luther
Violations: 4 code(s)
Record be1a0fdc
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 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: Steven E. Porter (Program Division Director), Sean M. Barclay
Triad Rx, Inc
Product: Drugs
Office: Office of Pharmaceutical Quality
People: Ronda R. Lloyd-Jones (Director of Compliance Branch), Matt Mcdonald
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