FDA 483 - Vesta Inc. - October 20, 2017

During an inspection, medical device manufacturer VESTA in Franklin, WI, was cited for significant deficiencies in process validation for its sterilizers, including failure to follow established protocols and a lack of objective evidence for critical steps. Additionally, the firm lacked adequate procedures for preventing contamination, specifically concerning environmental monitoring frequency and clean room sampling. These issues indicate a failure to ensure product quality and adherence to quality system requirements.