FDA WARNING_LETTER - ADVANCED SPECIALTY PHARMACY LLC - March 25, 2011

On March 23 and 25, 2011, the FDA inspected Advanced Specialty Pharmacy dba Meds IV, located in Birmingham, Alabama. The inspection revealed that several lots of Total Parenteral Nutrition (TPN) drug products were adulterated and misbranded.

The TPN drug products were found to be adulterated under Section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 351(a)(2)(A)]. On March 14, 2011, the firm was notified of positive cultures of *Serratia marcescens* in their TPN products, leading to a cessation of production on March 15, 2011. Testing by a contract laboratory and the Centers for Disease Control and Prevention (CDC) confirmed *Serratia marcescens* contamination in TPN units and in the blood cultures of patients who received the products. Environmental samples from the facility's anteroom tap water faucet also identified *Serratia marcescens* genetically indistinguishable from the strain found in a deceased patient's TPN isolate. This indicated the products were prepared, packed, or held under insanitary conditions.

Furthermore, the TPN drug products were misbranded under Sections 502(a) and 502(j) of the Act [21 USC 352