Nutrishare Inc – FDA 483, Jul 26, 2018

An FDA inspection of Nutrishare, Inc., a producer of sterile drug products in Louisville, KY, took place from July 16 to July 26, 2018. The inspection identified nine observations, indicating significant deviations from regulatory standards for the production of sterile drug products. Key issues included failures in aseptic processing, such as personnel obstructing critical airflow during sterile manipulations and insufficient dynamic certification of ISO 5 cleanroom environments. The facility's design allowed for poor material flow, exemplified by shared refrigeration units between the ISO 7 cleanroom and unclassified warehouse, potentially compromising sterile product integrity. Additionally, the firm did not adequately disinfect materials before introducing them into aseptic areas and utilized non-sterile disinfecting agents. Inadequate contact times for sporicidal agents were also noted. A critical concern was the lack of proper segregation and decontamination practices for beta-lactam drugs, which heightened the risk of cross-contamination with other sterile products. Gowning procedures were deemed improper, further increasing contamination risks, and unsealed ceiling tiles compromised the structural integrity of the cleanroom. Nutrishare, Inc. is expected to thoroughly investigate and correct these observations to ensure the safety, quality, and purity of its sterile drug products.