Maryland Specialty and Compounding Pharmacy – FDA 483, Mar 23, 2016

An FDA inspection of Professional Arts Pharmacy, a compounding pharmacy in Baltimore, MD, was conducted from March 2 to March 23, 2016. The inspection identified several critical violations related to the production of sterile drug products, indicating non-compliance with regulatory requirements. Key issues included significant deficiencies in aseptic processing areas, such as inadequate air filtration, absence of HEPA filters in the gowning room, and lack of environmental monitoring. Personnel gowning practices were found to be deficient, involving the use of non-sterile attire and exposed skin, posing contamination risks. The pharmacy lacked established procedures to prevent microbiological contamination, including monitoring differential pressures, performing dynamic smoke studies, and monitoring environmental surfaces like plastic curtains. Cleaning and disinfection protocols for aseptic areas were also inadequate, with observations of non-sterile wipes and insufficient cleaning. Furthermore, the firm exhibited deficient sterility testing procedures and concerns with determining product shelf-life. Component testing was also inadequate, with the use of non-pharmaceutical grade ingredients and failure to adjust component concentrations. Professional Arts Pharmacy is required to implement thorough corrective actions to address these observations and ensure compliance with quality and safety standards for compounded sterile drug products.