FDA 483 - Cascade Specialty Pharmacy, LLC - July 17, 2026

From July 6 to July 17, 2026, the FDA conducted an inspection of Cascade Specialty Pharmacy, LLC, located in Poulsbo, Washington. The inspection identified several critical failures in the firm"s manufacturing processes for non-sterile drug products. Key violations included the quality control unit"s failure to document appropriate container and closure systems for long-term storage, which could lead to drug degradation. Furthermore, batch production records were found to be incomplete; they lacked specific instructions for pulverizing tablets and transferring finished creams into syringes, making it impossible to ensure consistent product quality across different operators. The pharmacy also failed to verify that its cleaning agents effectively neutralized hazardous beta-lactam residues on shared equipment, relying instead on unverified manufacturer claims. A significant concern was the lack of finished product testing. The firm released medications based on theoretical calculations of strength rather than laboratory verification. Additionally, the pharmacy accepted raw materials from suppliers without performing its own identity tests and lacked a formal stability testing program to justify the expiration dates assigned to its products. Issued under the Federal Food, Drug, and Cosmetic (FD&C) Act, these observations require the firm to respond with corrective actions or objections to address the identified safety and quality risks. This report serves as a notice of findings rather than a final regulatory determination.