FDA 483 - East Orange VA Medical Center - April 29, 2025

An FDA inspection of East Orange VA Medical Center, a producer of sterile products, was conducted from April 22-29, 2025. The inspection, led by Investigator Logan T Williams, identified three observations related to facility conditions and manufacturing practices.

Observation 1 noted that production areas had difficult-to-clean or porous, particle-generating, or visibly dirty equipment/surfaces. Specifically, rust was found on a workbench table in the Segregated Compounding Area (SCA) (room -202A), approximately two feet from the ISO-5 Sterile Compounding area. Discoloration was observed on a HEPA pre-filter below an air return vent in the SCA. Additionally, puddled liquid was found in a cabinet within a closet adjacent to the SCA (room -167), which contained cleaners and a handwashing sink used prior to production.

Observation 2 highlighted the presence of sinks directly adjacent to the ISO-5 area. A sink in the SCA (room -202A) was approximately three feet from the ISO-5 Compounding Aseptic area and one foot from a storage bin containing materials for the ISO-5 area, including sterile gloves and hand-drying wipes. This sink is regularly used for drug product preparation for Veterans.

Observation 3 stated that Beta-lactam drugs were produced without adequate containment, segregation, and/or cleaning to prevent cross-contamination. The firm lacked policies for de