FDA 483 - Pharmcore Inc. dba Hallandale Pharmacy - September 24, 2021

An FDA inspection of Pharmcore Inc. dba Hallandale Pharmacy in Fort Lauderdale, FL, revealed significant deficiencies in their sterile drug production processes. Observations included inadequate cleaning procedures leading to potential cross-contamination, failure to take remedial action for microbial contamination in aseptic areas, and insufficient disinfection of materials entering sterile processing. These issues indicate a risk to product sterility and patient safety.