FDA 483 - Columbia River Pharmacy LLC (DBA Malley's Compounding Pharmacy) - August 16, 2019

An FDA inspection of Columbia River Pharmacy LLC, operating as Malley's Compounding Pharmacy and producing non-sterile drug products, was conducted from August 12-16, 2019. The inspection resulted in observations documented on an FDA Form 483, indicating potential non-compliance with regulatory standards.

The primary issues identified relate to facility controls and processes for preventing cross-contamination, particularly concerning hazardous drugs. Investigators observed inadequate containment and segregation practices, including hazardous bulk drug substances (such as hormones) stored alongside non-hazardous materials in the compounding lab. Furthermore, the firm failed to use a deactivating agent for cleaning non-dedicated equipment like hoods and utensils, and non-dedicated hoods were designed to vent exhaust back into the compounding room. Open storage of glassware without a door also contributed to contamination risks.

A second critical observation concerned the facility's design and its impact on air quality in controlled areas. The compounding lab's doorways were found to be propped open or lacking a door entirely, with a fan actively blowing air from the general pharmacy area into the more controlled compounding environment. This setup compromised the integrity of the air quality in the "higher classified area."

These observations highlight the need for Columbia River Pharmacy LLC to implement corrective actions to ensure proper containment, segregation, cleaning protocols, and adequate facility design to prevent cross-contamination and maintain appropriate environmental controls for drug production. The FDA 483 serves as a notice of these findings, requiring the company to address them.