FDA 483 - Carefusion 2200 Inc - October 11, 2022

Carefusion 2200 Inc, a medical device manufacturer in Vernon Hills, IL, underwent an FDA inspection from October 11 to October 19, 2022. The inspection resulted in two significant observations documented in an FDA Form 483, indicating deviations from quality system requirements under the Federal Food, Drug and Cosmetic Act.

The primary issue involved inadequate procedures for corrective and preventive action (CAPA). The company failed for over a decade to initiate proper CAPA, investigate root cause, or implement corrective actions for a known quality problem with its Class 2 Genesis STERRAD Reusable Rigid Sterilization Container Systems. Testing in 2011 revealed these containers were not an effective microbial barrier, compromising sterility. Furthermore, a CAPA opened in August 2022 contained inaccurate information, mischaracterizing consistent failures as "intermittent."

The second observation noted that the firm provided an inaccurate description of events leading to a recall (SUR-22-4516) for the same sterilization containers. The recall filing incorrectly described the failures as "intermittent test failures," when they were, in fact, clear test protocol failures in design validation and verification.

Carefusion 2200 Inc committed to correcting both identified observations to address these systemic quality management deficiencies.