Drugs

Sterile Drug Deficiencies at Option Care (Walgreens)

A 7/20-8/6/15 FDA inspection at Walgreens Home Care (now operating under the name Option Care Enterprises), San Antonio, TX, found serious deficiencies in the firm’s practices for producing sterile drug products that put patients at risk, according to a 10/19 Warning Letter from the agency’s Dallas District Office.

The letter says investigators observed that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions in which they may have become contaminated with filth or rendered injurious to health. And FDA laboratory analysis found gram-negative, gram-positive and spore-forming bacteria in a sample collected from the ISO 5 and ISO 7 locations within the company’s aseptic processing area, it says.

The District Office acknowledges the firm’s 11/2015 voluntary recall of sterile drug products within expiry and its responses addressing the insanitary conditions observed during the inspection and the corrective actions taken.

“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 aseptic processing experience could be useful in conducting this comprehensive evaluation.”

The company was told to take prompt action to correct the violations and to respond with a list of specific steps taken, documentation of each step, and a timetable for completion.

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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