FDA 483 - Central Admixture Pharmacy Services, Inc. - March 07, 2013

During an FDA inspection conducted from March 4-7, 2013, Central Admixture Pharmacy Services, Inc., a producer of sterile drug products in Homewood, AL, received a Form FDA 483 detailing significant observations of non-compliance with Current Good Manufacturing Practices (cGMP).

The primary issues centered on critical quality control and aseptic processing failures. The firm was observed distributing sterile drug products, including Cardioplegia and Oxytocin, without ensuring complete sterility, endotoxin, identity, and strength testing *prior* to release. Notably, some Cardioplegia batches that later failed sterility tests had already been distributed.

Further concerns involved deficient environmental controls, such as the absence of continuous monitoring for positive pressure differentials in clean rooms and inadequate environmental monitoring within laminar flow hoods during aseptic operations. Personnel were observed with exposed facial hair and skin, compromising sterility. Additionally, there were no written procedures for sporicidal cleaning agents in critical areas, and key process validations like bacterial retention testing and positive controls in media fills were lacking.

Other significant observations included a lack of a written stability program for sterile products, insufficient scope in discrepancy investigations, failure to retain reserve samples for drug lots, and non-adherence to complaint handling procedures. The company is expected to implement prompt and comprehensive corrective actions to address these serious deficiencies and achieve full regulatory compliance, ensuring the safety and quality of their sterile drug products.