FDA WARNING_LETTER - Assurance Infusion - December 03, 2019

On June 12, 2020, the FDA issued a Warning Letter to Nanobots Healthcare, LLC dba Assurance Infusion, following an inspection from November 13 to December 3, 2019. The inspection revealed serious deficiencies in the production of sterile drug products, leading to adulterated drugs under section 501(a)(2)(A) of the FDCA.

Key violations included: 1. Production with materials not verified for endotoxin contamination. 2. Failure to perform adequate dynamic smoke studies for ISO 5 unidirectional airflow. 3. Media fills not performed under challenging conditions, lacking assurance of aseptic production. 4. Personnel observed with exposed skin in the ISO 5 hood and re-entering the hood without sanitizing gloved hands. 5. Use of non-sterile wipers on ISO 5 work surfaces.

The firm ceased sterile compounding on December 19, 2019, and initiated a recall of all in-date sterile drug products on December 20, 2019. The FDA recommends a comprehensive assessment of operations, including facility design and aseptic processing, with a third-party consultant, if the firm intends to resume sterile drug production. The firm must respond within fifteen working days, detailing corrective actions or confirming no intent to resume sterile drug production, and notify the FDA fifteen working days prior to any resumption of sterile operations.