Drugs

CGMP Deviations at Aurobindo Facility

An FDA 8/2-8/12/21 inspection at the Aurobindo Pharmaceutical drug manufacturing facility in Doultabad, Telangana, India, found significant deviations from Current Good Manufacturing Practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 1/12 Warning Letter says the specific deviations were:

failing to evaluate the potential effect that changes may have on the quality of intermediates and APIs; and
failure of the site’s quality unit to ensure that critical deviations are investigated and resolved.

The letter says FDA raised similar CGMP deviations at a 7/29/19 regulatory meeting and the company proposed specific remediations at that time. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” the agency says.

FDA recommends that Aurobindo retain a qualified consultant to evaluate its operation and assist it in meeting CGMP requirements.

The firm was told to respond with a list of specific steps it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrections.

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