FDA WARNING_LETTER - Option Care - November 25, 2014

An FDA inspection of Walgreens Infusion Services (Houston, TX) from November 4-25, 2014, initiated by an adverse event complaint regarding a magnesium sulfate product, revealed serious deficiencies in sterile drug production. Investigators observed poor maintenance of ISO 5 and ISO 7 areas, including trash, debris, and dust in aseptic processing areas, and poor personnel practices (e.g., unsanitized gloves, retrieving gloves from the floor). Environmental samples from ISO 5 and ISO 7 areas tested positive for gram-negative, gram-positive, spore-forming bacteria, and mold, indicating a significant contamination risk.

The firm's drug products were deemed adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions. Specific violations included debris/dust in aseptic areas, poor personnel practices, failure to sanitize supplies/equipment, and failure to use sporicidal agents. Additionally, the magnesium sulfate product involved in the complaint was found to contain over 200% of the labeled strength, making it adulterated under section 501(b) and misbranded under section 502(a) of the FDCA.

The FDA acknowledged the firm's December 15, 2014, response to the Form FDA 483, and their voluntary recall of sterile products and temporary cessation of compounding on December 24, 2014