FDA 483 - Partners In Care, Inc. - March 07, 2017

During an inspection conducted from February 21 to March 7, 2017, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Partners In Care, Inc., a producer of sterile drugs located in Gainesville, GA. The inspection highlighted deficiencies in the aseptic processing areas, specifically concerning the system for cleaning and disinfecting rooms and equipment to maintain aseptic conditions.

The primary observation noted was the use of non-sterile wipes for critical cleaning procedures. Investigators observed that non-sterile wipes were utilized to clean drug components before their placement into the ISO 5 Laminar Flow Hood. Furthermore, the wipes employed for cleaning the ISO 5 Laminar Flow Hood itself were also found to be non-sterile. These practices are critical issues for a sterile drug producer, as they directly compromise the sterility of the environment and products, posing potential risks to patient safety.

This FDA 483 document serves as a notification of objectionable conditions observed during the inspection. Partners In Care, Inc. is expected to address these observations by implementing prompt and effective corrective actions. The company must review and revise its cleaning and disinfection protocols to ensure that only sterile materials are used in aseptic processing environments, thereby complying with regulatory standards for sterile drug manufacturing.