Biologics

CBER Posts 13 FDA Form-483s

CBER has begun to post, more proactively, inspection-related Form FDA-483s under the Freedom of Information Act’s provision on “frequently requested records.”

Under the regulation, FDA can release electronic copies of any records that have been previously released if it determines that the records are likely to be popular requests, or that they have already been requested three or more times.

This month alone, the following 13 Form FDA-483s were posted on CBER’s Web page:

09/24/2025 FDA Form 483 JMS Healthcare, Batangas, Philippines, May 2023

09/24/2025 FDA Form 483 IDT Biologika GmbH, Dessau-Rosslau, Germany Aug 2023

09/24/2025 FDA Form 483 GSK, Nord, France, March 2024

09/24/2025 FDA Form 483 GSK Vaccines GmbH, Marburg, Germany Feb 2024

09/23/2025 FDA Form 483 Capricor Inc., San Diego, CA May 2025

09/23/2025 FDA Form 483 ADMA Biologics Inc., Boca Raton, FL Dec 2024

09/05/2025 FDA Form 483 ARUP Laboratories, Inc, Sandy, UT Oct 2024

09/05/2025 FDA Form 483 Janssen, Raritan, NJ Oct 2024

09/05/2025 FDA Form 483 Patheon Italia SpA Monza, Italy Sept 2023

09/05/2025 FDA Form 483 SeaStar Medical Inc., Denver, CO Feb 2025

09/02/2025 FDA Form 483 Eone Laboratories, Incheon, Korea, Aug 2023

09/02/2025 FDA Form 483 Pfizer, Sanford, NC Nov 2023

09/02/2025 FDA Form 483 LFB Manufacturing, Gard, France, Sept 2022

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Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing