FDA 483 - ARJ Infusion Services Inc - May 25, 2017

This FDA Form 483 document details observations from an inspection related to sterile drug production. The facility's aseptic processing areas were found deficient in their environmental monitoring system. Specifically, the firm failed to perform media fills under worst-case processing conditions for their sterile processed drugs. The main pharmacy technician had not conducted a media fill at the current address.

Furthermore, dynamic smoke studies had not been performed in the laminar air flow hood. Air pressures were not monitored during sterile drug production or at any other time to ensure adequate pressure differentials were maintained in the anteroom, cleanroom, and laminar air flow hood. The inspection observed sterile processing of Normal Saline/Sodium Chloride 0.9% (raw material lots (b)(4) and (b)(4)) conducted by a Pharmacy Technician in the laminar air flow hood on May 16 and May 17, 2017. These observations indicate deficiencies in environmental control, process validation, and personnel qualification for sterile manufacturing operations.