PETNET Solutions, Inc. – FDA 483, Jan 9, 2026

PETNET Solutions, Inc. in Albany, NY, a PET Drug Manufacturer, was cited for significant deficiencies in its quality control laboratory operations. The inspection revealed that the firm's analytical methods were not adequately validated or suitable for their intended use, and it failed to properly investigate out-of-trend results. Furthermore, the firm repeatedly failed to conduct thorough investigations into out-of-specification results, instead invalidating them and releasing products without implementing necessary corrective and preventive actions.