483 Response Records
Browse through 113 483 response records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.
Showing 20 of 113 records
Catalent Massachusetts, LLC
Product: Drugs
Office: Division of Pharmaceutical Quality Operations I
People: Sarah McLaughlin (company_representative), Gordon Ashton (recipient)
Violations: 1 code(s)
Cosway Company, Inc.
Product: Drugs
Office: Food and Drug Administration
People: Amanda Lai (company_representative), Gregory V. Chambers (recipient), Steven E. Porter (Program Division Director)
Cosway Company, Inc.
Product: OTC (Over-the-Counter)
Office: Office of Regulatory Affairs
People: Amanda Lai (company_representative), 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
N-Molecular Inc. d.b.a. SOFIE
Product: Veterinary
People: William Crisp, Lori M. Newman (Deputy Director), Sean R. Marcsisin (Senior Consumer Safety Officer - Pharmaceutical Quality)
Record 40dcf4d8
Product: Food
Office: Dallas District Office
People: Enrique Dubols, Claire Minden (CO CDER OMQ), Susan Alverson
Violations: 4 code(s)
H & P Industries, Inc.
Product: Drugs
Office: Minneapolis District Office
People: Eric Haertle, Gerald J. Berg, Eric Wentorf
Violations: 1 code(s)
Snokist Growers
Product: Devices
Office: Center for Devices and Radiological Health
People: Lisa M. Althar, Jim Davis, Claudia Coles (President)
Violations: 1 code(s)
Abbott Medical
Product: Drugs
Office: Los Angeles District Office
People: Alonza E. Cruse (Director), Philip Tsung
Violations: 1 code(s)
Snokist Growers
Product: Tobacco
People: Miriam R. Burbach, Robert Lemke, Joseph Jimenez
Violations: 1 code(s)
Sunland, Inc.
Product: Devices
Office: Center for Devices and Radiological Health
People: Daniel J. Lahar (Cso), Isabel Y. Espinosa, Edith M. Gonzalez
Violations: 1 code(s)
Snokist Growers
Product: Devices
Office: Office of Health Technology 5 (Neurological and Physical Medicine Devices)
People: Charles M. Breen (District Director), Jim Davis, Claudia Coles (President)
Violations: 2 code(s)
Record 62a422f7
Office: Detroit District Office
People: Daniel H. Movens, Joanne M. Givens (Ms.), Judy Pulz
Everest Life Sciences LLC
Product: Food
Office: New Jersey District Office
People: Nancy Rolli, David P. Jacobus, Laura R. Jacobus
Violations: 1 code(s)
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