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Amended 483

Amended 483 Records

Browse through 7 amended 483 records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.

Amended 483 Records

Showing 7 of 7 records

California Pharmacy & Compounding Center

California Pharmacy & Compounding Center
•
Dec 7, 2018
•ID: d8565f55...

Product: Devices

Office: Center for Devices and Radiological Health

People: Linda Thai (Team Biologics Staff), Mariza Jafary, Ian M. Kuemerle

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Record 00b89fb1

Jul 22, 2019
•ID: 00b89fb1...

Product: Devices

Office: Center for Devices and Radiological Health

People: Christina K. Theodorou (Consumer Safety Officer), Jaime Della Paula

Violations: 1 code(s)

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KRS Global Biotechnology, Inc

KRS Global Biotechnology, Inc
•
Aug 6, 2019
•ID: 2aa78260...

Product: Devices

Office: Center for Devices and Radiological Health

People: Jennifer L. Huntington, Riccardo D. Roscetti

Violations: 5 code(s)

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Auro Pharmacies, Inc DBA Central Drugs

Auro Pharmacies, Inc DBA Central Drugs
•
Oct 1, 2019
•ID: 734ef494...

Product: Devices

Office: Center for Devices and Radiological Health

People: Bryan A. Galvez (Pharmaceutical investigator)

Violations: 3 code(s)

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Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
•
Dec 2, 2019
•ID: cf825ad2...

Product: Devices

Office: Center for Devices and Radiological Health

People: Erika V. Butler (Compliance Officer / Investigator), Navid Vahedi

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Abbott Laboratories

Abbott Laboratories
•
Sep 20, 2021
•ID: 5e83201b...

Product: Devices

Office: Center for Devices and Radiological Health

People: Daniel B. Arrecis (Investigator), Elizabeth P. Mayer, TJ Hathawa

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Wickliffe Pharmaceutical Inc

Wickliffe Pharmaceutical Inc
•
Sep 15, 2023
•ID: 5098ba4c...

Product: Devices

Office: Center for Devices and Radiological Health

People: Stephanie M. Mongeluzzi, Lauren N. Howard (Drug Specialist), Logan T. Williams (Investigator )

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