FDA 483 - P.E.T.NET HOUSTON, LLC - January 20, 2026

An FDA inspection of P.E.T.NET HOUSTON, LLC, a PET Drug Manufacturer, revealed significant deficiencies in facility design and contamination control. The firm's cleanroom design was inadequate to prevent contamination, and investigations into microbiological out-of-specification results were insufficient. These issues indicate a high risk to product quality and sterility assurance.