FDA EIR - MasterPharm LLC - January 30, 2017

An FDA inspection of MasterPharm LLC, a compounding pharmacy in South Richmond Hill, NY, was conducted from January 17-30, 2017. This inspection served as a follow-up to a previous audit in 2015 that identified significant issues, including insanitary conditions and deficiencies in aseptic processing, which led to a Warning Letter. Operating under Section 503A of the Federal Food, Drug and Cosmetic Act, MasterPharm LLC prepares patient-specific sterile and non-sterile compounded drug products, ranging from injectables to topical preparations. During the current inspection, the FDA issued a Form 483 with two main observations. First, the firm failed to conduct adequate aseptic process simulations, a critical step for qualifying personnel in sterile compounding techniques. Second, the inspection revealed a failure to adequately depyrogenate stoppers used in the production of sterile drug products, posing a risk of bacterial endotoxin contamination. Additionally, the inspection noted discrepancies in stability data supporting the assigned "beyond use dates" for certain sterile preparations, specifically Trimix formulations, which had proposed expiry dates exceeding the available supporting data. The firm also lacked process validation for certain in-house sterilization methods. MasterPharm LLC is required to submit a written response to the Agency addressing these observations within fifteen business days.