FDA WARNING_LETTER - pharmacy plus, inc. - October 13, 2022

The FDA issued a Warning Letter to Pharmacy Plus, Inc., dba Vital Care Compounder, following an inspection from October 3-13, 2022, which revealed serious deficiencies in sterile drug product production. The firm initiated a recall of sterile drug products on October 7, 2022, due to lack of sterility assurance.

The FDA found drug products to be adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions. Violations included: - Failure to take corrective action after microbial contamination in the ISO 5 aseptic processing area. - Difficult-to-clean, particle-generating, and visibly dirty equipment in the laminar airflow hood. - Use of non-sterile pads and wipers in the ISO 5 area (a repeat observation from 2016 and 2019). - Operator use of non-sterile tools and manual contact with inner surfaces of sterile drug product containers/closures. - Operator placing gloved hands outside ISO 5 area without re-sanitizing before re-entry. - Inadequate segregation and cleaning for hazardous drug production, risking cross-contamination. - Media fills not performed under challenging conditions, lacking assurance of aseptic production. - Failure to perform adequate dynamic smoke studies for unidirectional airflow in the ISO 5 area.

The FDA reviewed the firm's October 31, 2022