FDA 483 - First Pharma Associates LLC dba Riverpoint Pharmacy - December 16, 2016

On December 16, 2016, the FDA issued a Form 483 to First Pharma Associates, LLC dba Riverpoint Pharmacy, a producer of sterile drug products located at 528 E Spokane Falls Blvd, Suite 110, Spokane, WA 99202. The inspection, conducted from December 6-9 and 12-16, 2016, revealed four observations regarding facility conditions and quality systems.

Observation 1 noted that ISO-classified areas had difficult-to-clean, particle-generating, or visibly dirty equipment and surfaces. Specific issues included chipped drywall in the ISO 7 Buffer Room, apparent wood frames around HEPA filters, peeling laminate on a pass-through box, dust buildup on a light in the Prep Room, difficult-to-clean vinyl stools, black residue on a biological safety cabinet (BSC), orange buildup in the Buffer Room, buildup on a computer keyboard in the Powder Hood, and black staining on Buffer Room and Anteroom floors.

Observation 2 identified the presence of sinks or drains in the cleanroom where the ISO 5 area is located, specifically a hand wash sink in the Prep Room near a Powder Hood and BSC.

Observation 3 stated that the ISO 5 area was located within a non-classified room. The Prep Room, containing the ISO 5 BSC, was not supplied by HEPA-filtered air and was exposed to the