FDA 483 - Medi-Fare Drug - September 12, 2014

During an inspection on September 12, 2014, FDA investigators Viviana Mana and Richard Lyght observed deficiencies at an unnamed outsourcing facility.

The first observation concerns aseptic processing areas, specifically the cleaning and disinfection system. The firm uses non-sterile disinfecting agents inside ISO 5 Laminar Air Flow Work Benches. Additionally, disinfecting and sporicidal agents, including their dilution, used for aseptic processing areas, were not selected based on a formal assessment as required by the written and approved standard operating procedure 4.010: Cleaning Program, effective October 1, 2013. Contact times for these agents also need to be established.

The second observation relates to the labeling of the outsourcing facility's drug products, which do not include information required by section 503B (a)(10) of the Federal Food, Drug, and Cosmetic Act. Specifically, drug product labels do not include the date the drug was compounded (503B(a)(10)(A)), and drug product containers lack information to facilitate adverse event reporting and directions for use (503B(a)(10)(B)). These observations indicate issues with the firm's quality system regarding aseptic processing controls and compliance with drug product labeling regulations for outsourcing facilities.