FDA 483 - First Pharma Associates LLC dba Riverpoint Pharmacy - June 07, 2019

On June 7, 2019, the FDA issued a Form 483 to First Pharma Associates LLC, a producer of sterile and non-sterile drug products located at 1802 N Monroe St., Spokane, WA 99205, following an inspection conducted from May 31 to June 7, 2019. The report, addressed to Catherine M. Hudek, RPh, NCMP, Director of Pharmacy, detailed ten observations regarding facility operations and quality control.

Key observations included non-microbial contamination in the ISO-7 Buffer room, manual contact with container inner surfaces by personnel, and inadequate containment/segregation of hazardous drugs leading to potential cross-contamination. Specifically, the firm's wipe-down procedure for the hood used for both hazardous and non-hazardous substances was not proven to deactivate hazardous products, and shared utensils in the non-sterile lab were not adequately decontaminated.

Further issues involved ISO-5 classified areas not being certified under dynamic conditions (a repeat observation), personnel blocking first-pass air during aseptic manipulations, and poor personnel/material flow due to gowning practices. The facility design allowed lower quality air influx into higher classified areas, evidenced by an uncapped carboy under a sink. Inadequate pressure differentials between classified rooms were also noted. Media fills did not simulate challenging production conditions, and ISO-classified areas contained difficult-to-clean, particle-generating, or visibly dirty