ARJ Infusion Services Inc – FDA Warning Letter, May 25, 2017

On May 16-25, 2017, an FDA inspection of ARJ Infusion Services, Inc. identified serious deficiencies in sterile drug product production, leading to a Warning Letter. The firm's drug products are deemed adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions.

Violations include: 1. The main pharmacy technician had not performed a passing media fill at the current facility. 2. Inadequate smoke studies were performed, failing to demonstrate unidirectional airflow in the ISO 5 area, posing contamination risk. 3. The ISO 5 hood had rust with silicone applied (approx. ½” x 1”). 4. The ISO 5 hood had a crack along its overhead paneling (approx. 1 linear foot). 5. The pharmacy technician's beard cover exposed skin and hair during aseptic practices. 6. Components were not adequately sanitized before placement into the ISO 5 hood.

The FDA reviewed the firm's June 14, 2017, response to the Form FDA 483. While some corrective actions were adequate, others lacked sufficient information or supporting documentation. Specifically, the cleanroom certification noted significant recommendations that were not addressed with updated SOPs. The firm continued sterile drug production after the inspection despite the need for a new laminar flow hood, without providing rationale or assessment for product sterility during this period.