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

An FDA inspection of Pharmcore Inc. dba Hallandale Pharmacy, a producer of sterile and non-sterile drugs located at 2666 SW 36th St, Fort Lauderdale, FL, was conducted from September 13-24, 2021. The inspection identified three observations.

Observation 1 noted inadequate cleaning procedures to prevent cross-contamination. Specifically, the firm cleans the sterile hazardous compounding suite before the sterile non-hazardous suite, which could introduce hazardous materials into the non-hazardous area. Additionally, the technician does not re-gown between cleaning these suites.

Observation 2 indicated a failure to take remedial action when actionable microbial contamination was found in ISO 5 classified aseptic processing areas during production. The firm's QA Director stated a thorough clean is conducted only for objectionable microorganisms, but not for all actionable microbial contamination. Examples cited include *Staphylococcus epidermidis* isolated from an ISO5 biosafety cabinet (BSC) and laminar air flow hood (LAFH) on March 29, 2021; *Micrococcus luteus* from an ISO5 BSC on April 26, 2021; and *Bacillus megaterium* from an ISO5 BSC on April 8, 2021.

Observation 3 detailed that materials or supplies were not disinfected prior to entering aseptic processing areas. On September 15, 2021, a