FDA 483 - ark pharmacy, pc ( - February 24, 2022

During an inspection, the FDA observed that a non-pharmaceutical grade component, specifically (b)(4), was used in the formulation of a non-sterile drug product, (b)(4). This component was incorporated into the compounding process. The inspection revealed that a total of (b)(4) lots of the (b)(4) drug product were compounded using this non-pharmaceutical grade ingredient within the past six months. The specific lot numbers identified were (b)(4). This observation indicates a potential deviation from Good Manufacturing Practices (GMP) which require that components used in drug product manufacturing meet appropriate quality and purity standards, typically pharmaceutical grade, to ensure the safety, identity, strength, quality, and purity of the finished drug product. The use of non-pharmaceutical grade components can have significant business and operational implications, potentially leading to product recalls, regulatory actions, and damage to reputation.