FDA 483 - Pharmcore Inc. dba Hallandale Pharmacy - September 24, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 6257448b-1c45-4d99-bd0f-17dcc715705c