D.R. Pharmacy, Inc. – FDA 483, Mar 17, 2006

During an FDA inspection from March 13-17, 2006, D.R. Pharmacy, Inc. received a Form FDA 483 citing significant deviations in its compounded drug preparation operations. The observations highlighted a systemic failure to adhere to established quality standards and regulatory expectations.

Key issues included a widespread failure to follow standard operating procedures, such as not monitoring and documenting air temperature and humidity in compounding areas, neglecting visual checks for particulate matter in final products, and not conducting media fills. The firm also failed to perform potency testing for any compounded drug products since February 2003.

Environmental controls were deficient, with no documentation of laminar flow hood certification, lack of monitoring for air particulates or bioburden, and improper disinfection procedures. Equipment placement was observed to compromise critical airflow. Further concerns involved the absence of preservative effectiveness testing for routinely used substances, the unsanitary practice of re-using non-sterile protective garments, and improper storage of packaging materials.

Process validation was critically lacking, with no data to ensure effective homogenization of ingredients, consistent fill volumes, or proper sealing of product containers, leading to observed leaks. Moreover, the firm lacked stability data to support assigned expiration dates for compounded products, and numerous product lots were found without any expiration dates, posing potential patient safety risks. D.R. Pharmacy must comprehensively address these deficiencies by implementing validated procedures, robust quality controls, and thorough documentation to ensure product safety, quality, and compliance.