FDA EIR - Precision Nuclear of Virginia, LLC - November 19, 2015

An FDA inspection of Precision Nuclear of Virginia LLC, a Positron Emission Tomography (PET) drug manufacturer, was conducted from November 16-19, 2015. The inspection, guided by 21 CFR 212 for PET drugs, identified three primary issues. Firstly, the company did not ensure the cleanliness and suitability of its production areas and equipment before use. This included failing to adhere to established frequencies for changing delivery lines and inadequately documenting daily facility maintenance and sanitation procedures. Secondly, Precision Nuclear of Virginia LLC did not consistently follow its written quality assurance procedures. A significant concern was the failure to initiate corrective and preventive actions despite a recurring trend of invalid Bacterial Endotoxin Tests in January 2015. Additionally, there was no formal qualification program for personnel performing visual inspections of final products. Lastly, the firm failed to follow proper procedures for handling components, evidenced by expired production materials found in a rejection cabinet. In response, management acknowledged the observations and committed to implementing corrective and preventive actions. Voluntary corrections included disposing of expired materials, developing a qualification procedure for visual inspection, and adding state codes to lot numbers for site differentiation. The company committed to providing a written response to the FDA within 15 business days outlining its corrective measures.