FDA 483 - lincare, inc. - August 22, 2017

This FDA Form 483 observation details a deficiency at an unnamed facility concerning the use of a non-sterile disinfecting agent in ISO 5 classified areas. The firm utilizes a specific disinfectant, identified as (b)(4), which is not sterile. This non-sterile disinfectant is applied on a (b)(4) basis within the firm's (b)(4) laminar airflow hoods, specifically identified as (b)(4) and (b)(4). This practice raises concerns regarding the maintenance of sterility within critical processing environments, potentially impacting product quality and patient safety. The observation implies a deviation from expected good manufacturing practices (GMP) where sterile disinfectants are typically required for ISO 5 environments to prevent microbial contamination. The regulatory citation would likely relate to inadequate control of the aseptic processing environment.