FDA 483 - Foothills Professional Pharmacy, LTD - October 24, 2018

Foothills Professional Pharmacy, Ltd. in Phoenix, AZ, a producer of non-sterile drugs, was cited for significant quality control failures during an FDA inspection. The firm released sub-potent and super-potent drug products, used inadequate cleaning agents, and lacked proper procedures and testing for identity, strength, stability, and microbial limits, particularly for office-use products. Equipment was also found to be unsuitable and uncalibrated, indicating a broad breakdown in manufacturing and laboratory controls.