FDA 483 - Pharmcore Inc. dba Hallandale Pharmacy - July 13, 2018

The FDA inspection of Pharmacore Inc. dba Hallandale Pharmacy, a producer of sterile and non-sterile drugs, revealed significant deficiencies in environmental control and aseptic processing, indicating a lack of adherence to manufacturing quality standards. Observations, documented between July 2-13, 2018, included visibly dirty, particle-generating, or discolored equipment and surfaces within ISO 5 and ISO 7 classified cleanroom areas. The firm failed to maintain adequate controls to prevent contamination, evidenced by unauthorized holes in cleanroom walls, unsealed openings in biological safety cabinets, and patched areas compromising the sterile environment. Furthermore, environmental monitoring was deficient, as the company continued sterile operations even after an outside contractor reported an out-of-compliance air sample indicating fungal growth in a hazardous ISO 7 room. Personnel were observed not properly disinfecting gloves or materials when transitioning into aseptic processing areas. Finally, the ISO 5 classified areas lacked proper certification under dynamic conditions, which is crucial for ensuring product sterility. These observations highlight a failure to uphold essential Current Good Manufacturing Practice (cGMP) standards. The company is required to investigate these observations, implement comprehensive corrective actions, and submit a detailed response to the FDA outlining how they will address each deficiency and prevent recurrence.