FDA 483 - Pharmcore Inc. dba Hallandale Pharmacy - June 13, 2025

The FDA conducted an inspection of Pharmcore Inc., operating as Hallandale Pharmacy, located in Fort Lauderdale, FL, from June 3 to June 13, 2025. The inspection focused on the company"s production of sterile and non-sterile drug products. Key violations identified during the inspection include the improper exposure of materials to lower than ISO 5 quality air and inadequately performed smoke studies under dynamic conditions.

Specifically, sterile wipes stored in an ISO-7 cleanroom were used within the ISO-5 hood during sterile compounding processes, potentially compromising product sterility. This was observed during the production of various drug products, including Testosterone Cypionate/Anastrozole and NAD+ vials. Additionally, the firm"s smoke studies failed to fully simulate processing within the ISO-5 space, as essential equipment like filling needle stands and pumps were absent during these studies. Turbulent air was also noted in the most recent smoke study conducted on February 1, 2025.

These observations were made under the regulatory framework of the FD&C Act Section 704(b), which mandates that facilities maintain sanitary conditions to prevent contamination. Pharmcore Inc. is required to address these issues by implementing corrective actions to ensure compliance with FDA regulations. The company is encouraged to discuss objections or corrective plans with FDA representatives or submit them to the FDA for review.