FDA EIR - Smart World LLC - March 10, 2020

A routine, risk-based inspection of Smart World LLC., DBA Steri-Tek, a contract e-beam sterilizer registered with the FDA's Center for Devices and Radiological Health (CDRH), was conducted from March 5-10, 2020, in Fremont, CA. This inspection, performed under the Quality Systems Inspection Techniques (QSIT) framework, assessed the firm's sterilization processes and quality system, including management, corrective and preventive actions (CAPA), and production controls.

Significantly, the FDA found no new objectionable conditions or violations during this inspection. Consequently, no Form FDA 483, which details observations of potential regulatory violations, was issued. The inspection primarily served to verify the effective resolution of deficiencies identified in prior inspections.

The report confirmed that Steri-Tek had successfully corrected all issues raised in a previous 2017 inspection. These included inadequately established procedures for corrective and preventive actions, complaint handling, routine equipment calibration, and maintaining quality system records. Additionally, a single observation from a 2019 inspection regarding the failure to record and justify deviations was also verified as corrected. This inspection concluded without any outstanding regulatory concerns or new required actions for the company.