Drugs

3rd Eugia FDA-483 This Year So Far

FDA has released the form FDA-483 issued following a 3/28-4/5 inspection at the Eugia Steriles Private Limited drug manufacturing facility in Andhra, Pradesh, India. It was the third form FDA-483 issued to a Eugia facility in 2024 so far.

The three inspection observations on the latest form were:

failure to establish and follow procedures to prevent microbiological contamination of drug products purporting to be sterile;
failure to check input to and output from the computer and records or data for accuracy; and
failing to establish control procedures that validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

A February inspection at the firm’s sterile drug manufacturing facility in Telangana, India, drew a form FDA-483 with seven observations. There were nine observations on a 26-page form FDA-483 issued following a January inspection at the firm’s sterile drug manufacturing facility in Sangareddy, Telangana, India.

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

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome