FDA 483 - Medi-Fare Drug - June 21, 2013

This FDA Form 483 documents deficiencies at a facility engaged in sterile drug product manufacturing. The ISO 5 aseptic filling zone's design is inadequate, with plexiglass air foils failing to prevent microbial contamination. Smoke pattern studies from March 13, 2013, were deficient, showing diffuse airflow, smoke leakage through gaps, and not being conducted under dynamic conditions (e.g., maximum personnel, extended exposure, maximum batch sizes, or presence of equipment).

Personnel clothing is inappropriate, with operators wearing non-sterile gowns in the aseptic processing area. SOP 05-04-01, "Sterile Hand Hygiene and Garbing Procedure," lacks requirements for gown sampling. Procedures to prevent microbiological contamination are not established or followed; media fills do not simulate routine aseptic processing or worst-case conditions (e.g., maximum batch sizes, personnel, interventions, container/closure systems), being performed only for employee qualifications. Media fills on January 28, 2013, were inadequate and not representative of actual sterile drug production.

Glove fingertip sampling was not performed for sterile drug operations, only during fingertip monitoring, as per SOP 03-08-01, "Sterile Glove Fingertip Sampling." There is no formal written protocol for validation processes and data evaluation. Sterilization cycle parameters for product vials or finished product were supported only by open vials with biological indicators on April 23, 2