Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed

Biocon Sdn Bhd – 9/27/2024. Country: Malaysia. Record Type: 483

Brooklyn, NY – Prime Food Processing LLC is voluntarily recalling Dried Croaker Fish because the product was not adequately eviscerated, as required by the U.S. Food and Drug Administration (FDA). Fish that are not properly eviscerated may

Unapproved New Drugs/Misbranded

Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis due to risk of resistance during device withdrawal

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/22/2025
Short Title (70 char) Nephron Sc Inc. West Columbia, SC. 483 issued 08/22/2025
FEI Number 3010892830
Firm Name Nephron Sc Inc
Record Type 483
State SC
Establishment Type Sterile Drug Manufacturing

Guidance documents are prepared for FDA review staff and applicants/sponsors to provide guidelines to the processing, content, and evaluation/approval of applications and also to the design, production, manufacturing, and testing of regulated products.