FDA 483 - Colonia Care Pharmacy - April 22, 2019

An FDA inspection of Colonia Care Pharmacy, a producer of non-sterile and sterile drug products, was conducted from March 11 to April 22, 2019. The inspection resulted in several significant observations listed on an FDA Form 483. Key issues included the ISO 5 classified sterile compounding area being situated within an unclassified room without HEPA filtration, a repeat observation from a previous 2016 inspection, raising concerns about contamination control. Furthermore, the pharmacy was found to be using non-pharmaceutical grade components, specifically corn oil and olive oil, in the formulation of non-sterile veterinary drug products, impacting product quality and safety. Inadequate cleaning and environmental control practices in the sterile compounding areas were also noted, such as the reuse of sterile wipe pouches without validated sterility and evidence of corrosion on equipment. The firm also failed to perform adequate smoke studies to ensure unidirectional airflow under dynamic conditions. Colonia Care Pharmacy is expected to promptly address these observations to ensure compliance with regulatory standards for drug manufacturing and compounding.