Central Admixture Pharmacy Services, Inc. – FDA 483, Sep 19, 2016

The FDA Form 483 documents deficiencies in a facility's quality system and manufacturing practices, specifically regarding deviation investigation #37-160203-009 concerning microbial organisms in the cleanroom environment from January to August 2016.

A key violation is the failure to thoroughly review unexplained discrepancies. The investigation was deficient because microbial contamination (Phoma Spp.) found on January 18, 2016, on a (b) (4) used for Total Parenteral Nutrition (TPN) sterile IV products, primarily for neonatal intensive care unit (NICU) patients, was not addressed. The sterility testing process for TPN products, involving (b) (4) component samples, was deemed unrepresentative of finished product sterility.

While two other instances of microbial contamination in ISO Class 5 areas (April 20, 2016, and June 23, 2016) led to batch destruction, the TPN products from January 18, 2016, were released and distributed. The investigation's conclusion that these excursions had no impact on sterility or quality was challenged due to potential cross-contamination by pharmacists and technicians touching contaminated surfaces and then performing manipulations in ISO Class 5 environments. From January 19 to August 15, 2016, 25 instances of microorganisms were isolated from (b) (4) in the