Drugs

FDA-483 on Cadila Healthcare Inspection Posted

FDA has posted a Cadila Healthcare (a Zydus Lifesciences company) Form FDA-483 that provides details of GMP violations identified in a 3/10 FDA Webview story. For example, during FDA’s inspection of the firm’s Jarod, Gujarat (India) injectable facility between 2/24 and 3/10, the 483 cited Cadila's quality unit for failing to test about 250 stability samples within the time period specified in the company’s written stability testing program.

Another issue identified in the inspection was the firm’s written procedures not being followed for annual product quality reviews of its commercial drugs. Additionally, FDA said Cadila’s buildings used in the drug manufacturing and processing are not maintained in a “good state of repair.”

Cadila has a recent history of FDA compliance concerns. Earlier this year Viona Pharmaceuticals recalled 33 lots of Cadila-manufactured metformin HCl extended-release tablets 750 mg due to an out-of-specification result observed for the product that detected N-nitrosodimethylamine. An agency notice says the product was manufactured by Cadila’s Ahmedabad, India facility for U.S. distribution by Viona. And in 2019, FDA issued a Warning Letter after an inspection cited significant GMP violations.

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