FDA 483 - Promise Pharmacy, LLC - September 23, 2021

Promise Pharmacy, LLC in Palm Harbor, FL, was inspected and received a Form 483 with two observations. The inspection revealed the routine use of non-pharmaceutical grade components in the formulation of both sterile and non-sterile drug products. Additionally, personnel were observed failing to maintain aseptic technique by not changing or sanitizing gloves after touching non-ISO 5 surfaces before returning to aseptic processing.