Drugs

CGMP Problems Found in Fresenius Kabi Inspection

A 4/6-4/14/17 FDA inspection at Fresenius Kabi Oncology Limited, Hirnachal Pradesh, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/18/17 Warning Letter. The specific violation cited in the letter was failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed. The letter notes that FDA made a similar CGMP observation in a 5/14-5/22/15 inspection in which the company invalidated sterility test failures without adequately investigating the root causes.

“Although you proposed remediations in your responses following the 2015 inspection, and discussed these plans during a 2016 regulatory meeting with the agency, our current inspection found that your facility’s oversight and control over the manufacture of drugs remains deficient,” the letter says.

FDA says it strongly recommends that the company retain a qualified consultant to help it meet CGMP requirements. “In particular,” the letter says, “the consultant should assess risks in your manufacturing operation, retrospectively review all sterility failure investigations since 2014, retrospectively evaluate chemistry out-of-specification investigations to determine their adequacy, and assist with improvements to your investigation systems."

Fresenius was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.

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