Drugs

Sun Gets OAI Inspection at India Facility

FDA has classified a 12/4/2023 to 12/15/2023 inspection at Sun Pharmaceutical Industries’ Dadra, India facility as “official action indicated.” The classification is the agency’s most severe and requires corrections and often a follow-up inspection. “We will work with the regulator to achieve fully compliant status,” the company says in a financial release.

Sun’s compliance status has been getting increased regulatory attention for some time. Last year, FDA placed an import alert on drug products manufactured by Sun’s Gujrat, India facility due to significant GMP violations documented in a 5/2022 inspection of the facility. According to an FDA Letter referencing the import alert, 14 medically necessary products made by the company are being excluded from the alert as long as certain conditions are met. For example, medically necessary products will need to go through an independent third-party review that must include a detailed evaluation of all batch manufacturing records, in-process and finished product test results including the associated electronic data, all deviations, and applicable environmental monitoring records, as well as visual inspection records.

Earlier last year, the agency posted a “consent decree non-compliance” letter to the company outlining inspectional findings at the company’s Mohali (Punjab), India manufacturing facility that led to the agency ordering it to take additional corrective actions to get back into compliance with a 2012 consent decree (see earlier story). Sun Pharma inherited the facility when it acquired Ranbaxy Laboratories in 2015. In 2013, while Mohali was still part of Ranbaxy, the agency added it to the consent decree with Ranbaxy after two 2012 inspections found significant current good manufacturing practice regulation violations.

FDA’s non-compliance letter also ordered Sun Pharma to retain an independent GMP expert to inspect the facility for GMP compliance and to conduct batch certifications of drugs manufactured at the Mohali facility. In addition, the expert will need to submit to FDA for approval a written batch certification protocol applicable to all drugs Sun Pharma manufactures and tests at the facility. “Once FDA has approved the certification protocol, the GMP expert shall immediately begin witnessing the manufacture and testing of all drugs at the Mohali facility intended for distribution to the U.S.,” the letter 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