FDA 483 - PETNET Solutions, Inc. - February 21, 2020

An FDA inspection of PETNET Solutions, Inc. in Loma Linda, CA, revealed significant deficiencies in their PET drug manufacturing operations. Observations included inadequate production and process controls, failure to implement appropriate corrective and preventive actions for quality problems, and the use of expired components in drug production. These issues indicate a lack of control over critical manufacturing processes and quality systems.