FDA 483 - Hot Shots Nuclear Medicine, LLC - February 18, 2022

HotRax Nuclear Medicine, LLC dba Midwest Positron Technology, LLC, a PET Drug Manufacturer in Davenport, IA, was cited for two significant observations. The firm failed to implement and follow procedures for equipment cleaning, specifically regarding aseptic technique during production in an ISO 5 laminar airflow hood. Additionally, the company did not take appropriate corrective actions for multiple environmental monitoring action limit excursions, including inadequate follow-up on potential contaminated plates and failure to speciate microorganisms.