FDA 483 - Avenue Pharmacy Inc dba Pathway Pharmacy - June 22, 2021

Avenue Pharmacy Inc dba Pathway Pharmacy in Ocala, FL, was cited for significant deficiencies during an inspection from June 14-22, 2021. Observations included non-microbial contamination in the production area, specifically a grocery bag used to cover an opening on a hazardous hood. Additionally, the firm released drug products with incorrect strength, purity, or quality due to active pharmaceutical ingredients being weighed outside calibrated scale ranges.