FDA 483 - Medi-Fare Drug - May 26, 2023

An FDA inspection conducted at Medi-Fare Drug, an outsourcing facility located in Blacksburg, SC, from May 15 to May 26, 2023, revealed several significant deficiencies. The inspection report, known as an FDA Form 483, outlines four key observations regarding the firm's operations. Firstly, the company failed to ensure the reliability of component suppliers' analyses. Medi-Fare Drug accepted supplier Certificates of Analysis without conducting any independent testing to verify the conformity of components with specifications. This includes a complete absence of identity testing for raw materials upon receipt, which is crucial for drug product integrity. Secondly, issues were noted within the packaging and labeling system. The firm did not consistently visually examine representative units for correct labeling after finishing operations. A specific instance highlighted two batches of Ephedrine Sulfate manufactured with an erroneous National Drug Code (NDC) number on their labels, with one lot already distributed. Finally, deficiencies were identified in the facilities and equipment system, particularly concerning environmental control in aseptic processing areas. The firm utilizes critical processing areas that are not directly supplied with HEPA-filtered air, instead relying on passive airflow from an ISO 7 classified room. This practice raises concerns about potential contamination risks. These observations indicate a need for Medi-Fare Drug to implement comprehensive corrective actions to address these quality control and manufacturing practice shortcomings, thereby ensuring compliance with regulatory standards outlined under the Federal Food, Drug, and Cosmetic Act. The firm is expected to respond to these findings.