Drugs

HomeChoice Sterile Drug Product Deficiencies Cited

An 8/13-8/17/19 FDA inspection at a subsidiary of Option Care Health, HomeChoice Partners, doing business as Bioscrip Infusion Services, Augusta, GA, found “serious deficiencies in this facility’s practices for producing sterile drug products, which put patients at risk.” A 4/9 Warning Letter says specific deficiencies were:

failing to sanitize tubing between the production of different sterile drug products;
before cleaning, sterile wipes were introduced into the ISO 5 area for routine daily cleaning and some of the unused wipes were left for cleaning through the remainder of the day; and
vermin was observed in an area immediately adjacent to the production area.

The letter acknowledges some corrective measures reportedly taken by the company and asks for documentation. It also says the company failed to address some of the inspection observations.

“FDA strongly recommends that your management undertake a comprehensive assessment of operations, procedures, personnel, processes, maintenance, 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 experience should assist you in conducting this comprehensive evaluation.”

HomeChoice was told to take prompt action to correct the violations and to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation for each step and a schedule for completing all the actions.

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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