FDA 483 - ACRX Specialty Pharmacy Inc - March 20, 2019

The FDA Form 483 documents significant deficiencies at a facility manufacturing sterile drug products. Procedures to prevent microbiological contamination are not established, with multiple instances of personnel entering/exiting cleanrooms without proper disinfection or garbing changes. Sterile clothing used for cleaning was not replaced before production. Supplies were left in the LAFH, potentially disrupting airflow. Sterile solutions and wipes were observed open and exposed. Sterile garbing was reused.

Critical equipment, including depyrogenation and sterilization equipment, has never been qualified or calibrated. Dynamic smoke studies are absent. Media fills are infrequent and do not represent challenging processes. Sterilization process qualification studies have not been conducted. Environmental monitoring of ISO zones is only conducted quarterly, and pressure differentials are not monitored daily. Personnel monitoring is limited to gloved hands, quarterly. Alarm systems for air quality breaches are not employed.

The facility lacks a written stability testing program, and extended Beyond Use Dates (BUDs) are established without appropriate data. While sterility and potency data exist, other required stability data (including accelerated studies) were not provided. Ingredient stock solutions are used in multiple formulations. The distribution system is deficient, hindering product recall. Electronic records do not meet trustworthiness requirements. Written cleaning and maintenance procedures are inadequate.

Crucially, finished sterile drug products are not tested for sterility or endotoxins. Identity and strength of active ingredients are not confirmed prior to release. Complaint handling procedures are not followed, and drug products required to be free of objectionable microorganisms are not