Drugs

CGMP Violations at India’s Indoco Remedies

An 8/31-9/4/16 FDA inspection at Indoco Remedies, Goa, India found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 3/27 Warning Letter. Specific violations included:

failing to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product, including provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation; and
failing to ensure the responsibilities and procedures applicable to the quality control unit are followed.

The letter says that in a 2/18-2/23/11 inspection, FDA cited a similar CGMP observation involving leakage in drug products. “These repeated failures demonstrate that your facility’s oversight and control over the manufacture of drugs are inadequate,” it says. “You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately the products manufactured, conform to FDA requirements.”

The agency recommended that Indoco engage a consultant to assist it in meeting CGMP requirements. The company was told to respond with a list of steps taken since the inspection to correct the violations and prevent them from recurring.

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