Option Care – FDA Warning Letter, Sep 21, 2016

The FDA issued a Warning Letter to Option Care Enterprises, Inc. following an inspection from September 1 to September 21, 2016, at their Wood Dale, IL facility. The inspection revealed serious deficiencies in sterile drug product production, leading to drug products being adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions.

Violations included poor aseptic practices by operators, such as rapid movement within the ISO 5 area disrupting airflow, incomplete disinfection of components and materials during transitions between air quality areas (e.g., ISO 7 to ISO 5), and improper storage of wipes in the ISO 7 cleanroom, increasing contamination risk. These acts are prohibited under sections 301(a) and 301(k) of the FDCA.

The firm's October 12, 2016, response to the FDA 483 was deemed inadequate. Retraining on aseptic technique (SOP P-132) lacked supporting documentation. Proposed smoke studies for rapid movement in ISO 5 were insufficient, as quick movement inherently risks contamination. Storing wipes in an open-top bin was considered inconsistent with best practices despite the firm's claim of USP <797> compliance.

FDA strongly recommended a comprehensive assessment of operations, particularly aseptic processing, with assistance from a third-party consultant. The letter emphasized that 501(