FDA WARNING_LETTER - sharp drugs, inc. - July 13, 2018

On August 2, 2019, the FDA issued a Warning Letter to Sharp Drugs, Inc. dba Island Drug and Surgical, following an inspection from July 10-13, 2018. The inspection revealed serious deficiencies in the production of sterile drug products, leading to the classification of these products as adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions.

Key violations included: - The biological safety cabinet (BSC) for sterile processing was in a non-classified room without HEPA filtration. - The BSC was turned off when not in use and not re-cleaned before sterile processing. - Non-sterile materials (cleaning solutions, paper towels, wipes, gloves) were used in sterile processing and for cleaning the BSC. - No sporicidal agent was used in the ISO 5 aseptic processing area. - Materials were transferred into the BSC without disinfection. - Inadequate smoke studies were performed, failing to demonstrate unidirectional airflow. - No media fills had been performed, indicating a lack of assurance in aseptic production.

The firm voluntarily ceased all sterile production on July 18, 2018. The FDA acknowledged this and recommended a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems, preferably with a third-party consultant, if the firm intends to resume sterile operations. The