Drugs

Intrathecal Compounding Specialist Inspection Violations

A 2/6-2/14/19 FDA inspection at Intrathecal Compounding Specialist, Scott, LA, found serious deficiencies in the firm’s practices for producing sterile drug products that put patients at risk. A 9/15 Warning Letter gives examples of the firm preparing, packing, or holding drug products intended or expected to be sterile under insanitary conditions, whereby they have become contaminated with filth or rendered injurious to health. Specific examples were:

continuing to produce and distribute sterile drug products during and after maintenance on the HVAC system;
failing to maintain adequate pressure differentials between areas of higher quality and lower quality air;
failing to use a sporicidal agent as part of the aseptic processing area disinfection program;
failing to perform media fills under the most challenging or stressful conditions, this failing to assure that the firm can aseptically produce drug products intended to be sterile within its facility;
personnel donned and reused gowning material improperly, which may have caused the gowning material to become contaminated; and
firm personnel were observed using poor aseptic technique, which included leaning into the ISO 5 laminar flow hood.

The letter says FDA reviewed the firm’s responses to an FDA-483 and found that some appeared to be adequate while the adequacy of others could not be determined.

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

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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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