Drugs

5 Observations in Alembic FDA Inspection

An FDA inspection at the Alembic Pharmaceuticals solid oral drug formulation manufacturing facility in Jarod, Gujarat, India, resulted in an FDA-483 with five observations. The Indian financial news platform BQ Prime reports the company disclosed the 12/8-12/16/22 inspection in a financial exchange filing. BQ Prime says it obtained these five inspection observations from FDA:

equipment and utensils are not cleaned or sanitized at appropriate intervals to prevent contamination that could affect the safety and quality of the drug;
failing to establish procedures designed to prevent objectionable microorganisms in drug products not required to be sterile;
failing to establish adequate written procedures for production and process controls designed to assure the quality and purity of drug products.
aseptic processing areas are deficient in systems for monitoring environmental conditions; and
failing to fully follow the responsibilities and procedures applicable to the quality control unit.

In its filing, Alembic said none of the observations related to data integrity and said the company would respond to FDA within the required time.

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