Drugs

CGMP Violations Found in Eugia Pharma Inspection

A 2/16-2/27 FDA inspection at the Eugia Pharma drug manufacturing facility in Kolthur Village, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/13 Warning Letter says the specific violations were:

failure to perform operations within specifically defined areas of adequate size, and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas; and
failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes.

The letter notes that similar CGMP violations were found in other Eugia facilities and says that repeated failures at multiple sites “demonstrate that management oversight and control over the manufacture of drugs are inadequate.”

FDA says Eugia should promptly address the violations and ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence. “It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations,” the agency says.

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