Drugs

Metro Drugs Sterile Drug Deficiencies Noted

A 3/14/19-4/5/19 FDA inspection at Metro Drugs 3^rd Avenue Corp., New York, NY, found deficiencies in the company practices for producing sterile drug products, putting patients at risk. A just-released 1/8 Notice of Violation says specific violations were:

drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions where they may have become contaminated with filth or rendered injurious to health, causing the products to be adulterated;
analysis showed that the firm’s Tri-Mix Quad (alprostadil 10mcg/papaverine 12 mg/phentolamine 1mg/atropine 0.15mg/mL) contained 134.5% of the labeled concentration of atropine sulfate monohydrate, rendering it misbranded.

The letter says some of the firm’s proposed corrective actions for the insanitary conditions appear adequate. However, the agency says it cannot evaluate other proposed corrective actions described in the company’s response because it did not include sufficient information or supporting documentation.

Metro was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with related documentation and a timetable for completing the work.

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