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483 Response

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.

483 Response Records

Showing 20 of 113 records

Catalent Massachusetts, LLC

Catalent Massachusetts, LLC
•
Nov 30, 2021
•ID: 8d25ff3a...

Product: Drugs

Office: Division of Pharmaceutical Quality Operations I

People: Sarah McLaughlin (company_representative), Gordon Ashton (recipient)

Violations: 1 code(s)

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Cosway Company, Inc.

Cosway Company, Inc.
•
Feb 24, 2023
•ID: 9f5985aa...

Product: Drugs

Office: Food and Drug Administration

People: Amanda Lai (company_representative), Gregory V. Chambers (recipient), Steven E. Porter (Program Division Director)

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Organic Pastures

Organic Pastures
•
Oct 9, 2019
•ID: d4c04bfe...

Office: San Francisco District Office

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Cosway Company, Inc.

Cosway Company, Inc.
•
Oct 27, 2023
•ID: 8ef278b0...

Product: OTC (Over-the-Counter)

Office: Office of Regulatory Affairs

People: Amanda Lai (company_representative), Sara H. Gabel, Kenneth O. Gee (Consumer Safety Officer)

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Agility Medical Research, Inc.

Agility Medical Research, Inc.
•
Dec 21, 2022
•ID: 48a88842...

Product: Other

Office: Office of Bioresearch Monitoring Inspectorate

People: Richard A. Lyght

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N-Molecular Inc. d.b.a. SOFIE

N-Molecular Inc. d.b.a. SOFIE
•
Nov 7, 2024
•ID: 106aaead...

Product: Veterinary

People: William Crisp, Lori M. Newman (Deputy Director), Sean R. Marcsisin (Senior Consumer Safety Officer - Pharmaceutical Quality)

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Record 40dcf4d8

Jun 27, 2014
•ID: 40dcf4d8...

Product: Food

Office: Dallas District Office

People: Enrique Dubols, Susan Alverson, Charles J. Chacko

Violations: 4 code(s)

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H & P Industries, Inc.

H & P Industries, Inc.
•
Jan 7, 2011
•ID: 709ed66b...

Product: Drugs

Office: Minneapolis District Office

People: Eric Haertle, Gerald J. Berg, Eric Wentorf

Violations: 1 code(s)

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Snokist Growers

Snokist Growers
•
Jun 2, 2011
•ID: 85affccd...

Product: Drugs

Violations: 2 code(s)

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Snokist Growers

Snokist Growers
•
Nov 1, 2011
•ID: 16ad6fd6...

Product: Devices

Office: Center for Devices and Radiological Health

People: Lisa M. Althar, Jim Davis, Claudia Coles (President)

Violations: 1 code(s)

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Abbott Medical

Abbott Medical
•
Oct 17, 2012
•ID: 581f7586...

Product: Drugs

Office: Los Angeles District Office

People: Alonza E. Cruse (Director), Philip Tsung

Violations: 1 code(s)

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Sunland, Inc.

Sunland, Inc.
•
Sep 23, 2010
•ID: f6525806...

Product: Tobacco

Violations: 1 code(s)

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Snokist Growers

Snokist Growers
•
Aug 5, 2011
•ID: e250a4e4...

Product: Tobacco

People: Miriam R. Burbach, Robert Lemke, Joseph Jimenez

Violations: 1 code(s)

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Sunland, Inc.

Sunland, Inc.
•
Oct 16, 2012
•ID: 29386302...

Product: Devices

Office: Center for Devices and Radiological Health

People: Daniel J. Lahar (Cso), Isabel Y. Espinosa, Edith M. Gonzalez

Violations: 1 code(s)

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Sunland, Inc.

Sunland, Inc.
•
Mar 10, 2009
•ID: 922c5395...

Product: Drugs

People: Jimmie D. Shearer, Tom Warwick (Mr. H.)

Violations: 5 code(s)

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Sunland, Inc.

Sunland, Inc.
•
Mar 25, 2011
•ID: 1df14ecd...

Product: Tobacco

People: Carolyn A. Pinney

Violations: 2 code(s)

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Snokist Growers

Snokist Growers
•
Jun 2, 2011
•ID: 33f903bc...

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)

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Infupharma LLC d.b.a. President Pharmacy

Infupharma LLC d.b.a. President Pharmacy
•
Oct 12, 2011
•ID: 17705e61...

Office: Florida District Office

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Record 62a422f7

Oct 24, 2008
•ID: 62a422f7...

Office: Detroit District Office

People: Daniel H. Movens, Joanne M. Givens (Ms.), Judy Pulz

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Everest Life Sciences LLC

Everest Life Sciences LLC
•
Feb 18, 2011
•ID: a6843c30...

Product: Food

Office: New Jersey District Office

People: Nancy Rolli, David P. Jacobus, Laura R. Jacobus

Violations: 1 code(s)

View Details
Showing 1 to 20 of 113 records
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