FDA 483 - Accurate RX Pharmacy Consulting LLC - August 14, 2017

This FDA Form 483 was issued to Accurate Rx Pharmacy Consulting, LLC dba Accurate Rx Pharmacy, a producer of sterile drugs located at 103 Corporate Lake Drive, Suite B, Columbia, MO 65203-7290. The inspection was conducted on July 31, August 1, August 8, and August 14, 2017, by Investigator Veronica Fuentes, and the report was issued on August 15, 2017, to Jay R. Bryant-Wimp, Pharmacist in Charge.

The sole observation noted was that the ISO 5 classified workstation, where sterile products are prepared, is located within a non-classified room. Specifically: A. The "compounding aseptic isolator" is not situated in a controlled environment/room, increasing contamination risk. On July 31, 2017, during saline water bag production, the isolator was observed to be equipped with a specific component and was not completely enclosed to the environment. Furthermore, the isolator is not used daily and is turned off when not in use, impacting cleaning and disinfection procedures. B. The ISO 5 classified area is in close proximity to a sink, with no barriers between the sink and the "compounding aseptic isolator" to prevent contamination.