FDA Drugs· FDA·· 7 hours agoScore50
Northland Nuclear Medicine, LLC - 736893 - 10/22/2026
In brief
FDA issued a warning letter to Northland Nuclear Medicine, LLC on October 22, 2026, for CGMP violations involving PET drugs. Between March 2024 and April 2026, environmental monitoring in ISO 5 areas recorded more than 100 microbial recoveries, but investigations, root cause analyses, and CAPAs were inadequate; the firm's response to the Form FDA 483 was also deemed inadequate. The PET drug products are deemed adulterated.
Source: FDA Drugs · fda.gov