Hot Shots Nm, LLC – FDA 483, Feb 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.
ID · 2a6b5336-088c-42e4-9ee3-9f6b60007bfc
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