FDA 483 - International Sterilization Laboratory, LLC - October 10, 2019

An FDA inspection conducted at International Sterilization Laboratory, LLC, a medical device contract sterilizer located in Groveland, FL, occurred from October 8-10, 2019. The inspection resulted in observations documented on Form FDA 483, indicating deficiencies in the company's quality system, specifically regarding its corrective and preventive action (CAPA) procedures. The primary issue identified was that the company's procedures for CAPA were not adequately established. Specifically, the FDA observed that actions taken in response to complaints, nonconformance reports, or sterility failure investigations were not consistently identified as corrective actions. Consequently, these actions lacked the required documentation for verifying their effectiveness or confirming they would not negatively impact the quality of finished medical devices. Furthermore, the inspection noted a lack of clear justification for classifying certain nonconformances as low risk, thereby exempting them from requiring consideration for corrective or preventive action, as outlined in the company's own procedures. As an FDA-regulated entity, International Sterilization Laboratory, LLC is responsible for addressing these observations. The company must implement comprehensive and effective CAPA procedures, ensuring all relevant issues are properly identified, documented, and evaluated for effectiveness to maintain compliance with medical device quality system regulations.