FDA 483 - Infusion Options, Inc. - June 25, 2019

This FDA Form 483 details observations from an inspection of Infusion Options, Inc., an outsourcing facility located at 5924 13th Ave, Brooklyn, NY, conducted from May 6 to June 25, 2019. Estee Altman is the CEO.

The inspection revealed 17 observations related to drug product storage, aseptic processing, facility control, quality systems, and regulatory compliance.

Key violations include: - **Improper Storage:** Drug products requiring refrigeration were stored in an actively used warehouse bathroom, compromising identity, strength, quality, and purity. Lack of document control for these products was noted. - **Aseptic Technique Deficiencies:** Numerous failures in aseptic processing were observed, including operators disrupting ISO-5 HEPA airflow, inadequate disinfection contact time, improper material transfer techniques (e.g., throwing bags into LAF, bare-arm transfers), and poor gowning practices (e.g., ungowned personnel in clean areas, touching floor with gowns, inadequate goggle use). - **Unauthorized Access:** Untrained personnel, including a driver, accessed aseptic areas ungowned and handled compounding materials. - **Procedure Non-Adherence:** Expired Dextrose 5% IV bags were used for drug preparation. - **Environmental Monitoring Deficiencies:** Lack of continuous non-viable particulate testing in ISO 5 areas and issues with HEPA filters were noted. - **Facility Maintenance:**