Medi-Fare only uses active and inactive ingredients sourced from FDA registered and inspected facilities to custom compound complex sterile injections for your needs during critical drug shortages. Medi-Fare was one of the first in the nation to become a FDA-registered 503B Outsourcing Facility. In 2012, Medi-Fare completed construction on a state-of-the-art clean room. Our new clean room is custom designed and is constructed with employee safety, product quality, and production efficiency in mind. The production environment is specifically suited for the on-site compounding of a wide variety of sterile products including injectables, ophthalmics, intrathecals, otics, irrigations, allergy tests and diagnostic agents. Our facility surpasses the minimum guidelines for clean room design, operation and maintenance as determined by the United States Pharmacopeia - the national standard setting body for drugs, chemicals and foods and more importantly is a current Good Manufacturing Practices (cGMP) compliant facility as defined by the Food & Drug Administration. This new facility will help us maintain our commitment to "Continuous Quality Improvement." Our meticulous attention to detail from environmental testing, clean room sanitization, and personnel testing, to real-time particulate monitoring ensures sterility is maintained at every step of the processes. All of our preparations undergo rigorous testing by third-party, independent FDA registered laboratories that evaluate a wide range of criteria including potency, sterility, pyrogens and stability that provides you with assurances and confidence that the sterile compounded preparations you receive from Medi-Fare are safe for your patients and your institution. Each formulation that we undertake has been put through a rigorous Process Validation which ensures uniformity and reproducibility of that formula each and every time it is made.
