FDA WARNING_LETTER - Columbia Presbyterian Medical Center - June 19, 2008

On December 22, 2008, the FDA issued a Warning Letter to Kreitchman PET Center following an inspection from June 3 to June 19, 2008. The inspection revealed significant deviations from USP compounding standards and official monographs for PET drugs (Fludeoxyglucose (FDG) F 18 Injection, Ammonia N 13 Injection, Water O 15 Injection, and Oxygen O 15 Gas), rendering the products adulterated under Section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

The FDA found the August 18, 2008, response to the FDA-483 inadequate, noting many repeat violations from a 2004 inspection. Deficiencies were identified in Quality, Production, Laboratory, and Facilities and Equipment systems. Key violations included: 1. Failure to investigate unacceptable quality control test results (e.g., OOS sterility for FDG lot F051508-1, OOS residual solvents for FDG lot F052208-1) and document outcomes, with retesting performed without invalidating the first test. 2. Failure to reject out-of-specification batches (e.g., FDG batch F072607-1 for acetonitrile), maintain raw analytical data, and conduct verification studies for revised compounding procedures. 3