FDA 483 - Poulsbo Compounding Pharmacy LLC, dba Cascade Specialty Pharmacy - March 11, 2019

An FDA inspection conducted from March 11 to April 17, 2019, at Poulsbo Compounding Pharmacy LLC, operating as Cascade Specialty Pharmacy, revealed significant deficiencies in their manufacturing processes for both sterile and non-sterile drug products. The observations, documented on an FDA Form 483, highlighted critical issues primarily related to maintaining environmental control and preventing contamination.

Key violations included inadequate response to microbial contamination in ISO 5 aseptic processing areas, where high bacterial counts were detected but production continued without proper remediation or re-testing. The facility also exhibited deficient environmental monitoring controls, such as a lack of a smoke study for new equipment, infrequent testing, and insufficient microbial testing of sterile product batches.

Furthermore, the pharmacy failed to adequately prevent cross-contamination, particularly with beta-lactam drugs. This involved using non-dedicated equipment, insufficient cleaning procedures, improper storage, and an interconnected air handling system that risked contaminating clean areas. Facility design issues, like an open door to a cleanroom, and the use of non-sterile cleaning agents further compromised aseptic conditions. Personnel practices were also found lacking, with infrequent glove changes and inadequate equipment cleaning leading to visible residues.

The firm also used non-pharmaceutical grade components and stored sensitive ingredients improperly, potentially affecting product quality and efficacy, with patient complaints noted. Cascade Specialty Pharmacy is required to promptly address these observations by implementing comprehensive corrective and preventive actions to ensure the safety, quality, and purity of their drug products.