FDA 483 - First Pharma Associates LLC dba Riverpoint Pharmacy - March 03, 2021

On March 3, 2021, the FDA issued a Form 483 to First Pharma Associates LLC dba Riverpoint Pharmacy, located at 1802 N Monroe St, Spokane, WA 99205-4528. The inspection, conducted from February 23 to March 3, 2021, identified one observation regarding the firm's production of non-sterile drug products.

The observation noted that the firm produced highly potent drugs without providing adequate cleaning of utensils to prevent cross-contamination. Specifically, on February 24, 2021, an employee was observed compounding multiple lots of non-sterile hazardous human drug products. During this process, product-contact metal stir axels were cleaned with an expired solution (lot # with expiration date 10/19) between lots of different products. This was observed during the manufacturing of Estradiol 0.5mg/Estriol 0.5mg/gm vaginal cream, lot 02242021@1, and subsequently Estriol vaginal cream 2mg/0.5mg, lot 02242021@3, using potentially the same stir axel. The report was issued to Erik J. Nelson, Owner and Pharmacist-in-Charge.