Drugs

Lincare Warned About Sterile Drug Violations

A 6/1-6/12/15 FDA inspection at Lincare Holdings (United Medical Home Infusion), Little Rock, AR, found “serious deficiencies” in the firm’s practices for producing sterile drug products, putting patients at risk, according to a 4/25 Warning Letter from the agency’s Dallas District Office. The letter says the inspection was conducted in response to information received from the Arkansas State Board of Pharmacy reporting that four patients were hospitalized after receiving the firm’s Total Parenteral Nutrition products. Specific violations detailed on an FDA-483 included preparing, packing, or holding under insanitary conditions drug products intended or expected to be sterile.

The letter acknowledges the firm’s 5/30/15 action to stop compounding sterile drug products and its 6/9/15 action to recall all sterile drug products within expiry. It says that FDA was informed that Lincare resumed sterile compounding operations 8/28/15. FDA says that while some of the firm’s proposed corrective actions appeared adequate as detailed in 7/2/15 and 1/12 letters, others were deficient.

“FDA strongly recommends that your firm’s 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.”

Lincare was told to take prompt steps to correct the violations and to respond with a list of steps taken, 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