Drugs

FDA Flags Quality Control Lapses at Indian API Maker

FDA has cited an Indian drug manufacturer for deficiencies in laboratory testing and quality control procedures following an inspection conducted in December. According to a just-posted Form FDA-483 issued to SMS Pharmaceuticals Limited, Unit VII, an active pharmaceutical ingredient (API) manufacturing facility in Andhra Pradesh, investigators identified failures to ensure that testing specifications were “scientifically sound” and properly applied to confirm product quality and purity.

FDA’s primary observation centers on the company’s handling of extraneous matter testing, a key quality metric for APIs. Inspectors found that while the firm had established internal procedures and specifications, it did not consistently follow them when evaluating batch results.

Specifically, the agency said the company failed to use the correct particle count calculations required under its own testing protocol, potentially leading to inaccurate conclusions about whether a batch met quality standards.

In one cited example, a batch of API intended for the U.S. market was recorded as passing the extraneous matter test based on incomplete or improperly interpreted data. However, when assessed using the full criteria outlined in the company’s procedure, the results would have indicated a failure.

Despite the discrepancy, the batch in question was released and shipped to the U.S., raising concerns about the reliability of the firm’s quality assurance processes.

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