Drugs

‘Insanitary’ Conditions Found at Advanced Care Infusion

A 2/12-2/23/15 FDA inspection at Tri-Med, Inc., (doing business as Advanced Care Infusion-Shelby), Shelby Twp., MI, found “serious deficiencies” in the firm’s practices for producing sterile drugs, according to a just-released 12/18/15 Warning Letter from the agency’s Detroit District Office. “The FDA investigator observed that your sterile drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated,” the letter declares.

Several examples are given of observations indicating that the firm’s products “may be produced in an environment that poses a significant contamination risk.”

The letter says that some of the firm’s proposed corrective actions appear adequate, while others are deficient. “FDA strongly recommends that your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems,” the letter says. “In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation.”

Tri-Med was told to respond with a list of specific steps taken to correct the violations, with documentation of each step and a timetable for completion.

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