483 Response Records
Browse through 115 483 response records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.
Showing 20 of 115 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)
Product: Food
Office: Dallas District Office
People: Enrique Dubols, William A. Stuart, Charles J. Chacko
Violations: 4 code(s)
H & P Industries, Inc.
Product: Drugs
Office: Minneapolis District Office
People: Eric Wentorf, Eric Haertle, Gerald J. Berg
Violations: 1 code(s)
Snokist Growers
Product: Devices
Office: Center for Devices and Radiological Health
People: Jim Davis, Lisa M. Althar, Claudia Coles (President)
Violations: 1 code(s)
Abbott Medical
Product: Drugs
Office: Los Angeles District Office
People: Philip Tsung, Alonza E. Cruse (Director)
Violations: 1 code(s)
Snokist Growers
Product: Tobacco
People: Robert Lemke, Steven E. Porter (Program Division Director), Kenneth Gibbs
Violations: 1 code(s)
Sunland, Inc.
Product: Devices
Office: Center for Devices and Radiological Health
People: Gloria A. Milster, Jimmie D. Shearer, Edith M. Gonzalez
Violations: 1 code(s)
Snokist Growers
Product: Devices
Office: Office of Health Technology 5 (Neurological and Physical Medicine Devices)
People: Jim Davis, Claudia Coles (President), Charles M. Breen (District Director)
Violations: 2 code(s)
Everest Life Sciences LLC
Product: Food
Office: New Jersey District Office
People: Laura R. Jacobus, Atul J. Agrawal (Regulatory Affairs), David P. Jacobus
Violations: 1 code(s)
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