FDA EIR - Smart World LLC - April 10, 2019

An FDA inspection of Smart World LLC., DBA Steri-Tek, a contract sterilizer in Fremont, CA, was conducted from April 8-10, 2019. This inspection primarily focused on the company's pharmaceutical operations, specifically concerning the sterilization of a sterile device component, under the regulatory framework of 21 CFR 211.The main violation documented on an FDA Form 483 observation was the failure to record and justify deviations from written production and process control procedures. Specifically, the radiation services team disqualified a dose map run for a critical sterilization performance qualification without proper documentation, investigation, or notification to the quality unit.Additionally, general discussions with management highlighted other areas needing improvement, including the lack of a formal quality review for certain process control forms, particularly those for beam sweep and energy measurements. The inspection also identified the absence of a recall procedure, which is essential given the company's role in the product lifecycle.Management, including the CEO and Quality Manager, acknowledged these issues and committed to implementing corrective actions. They promised a written response to the FDA 483 observation within 15 business days, to immediately implement quality review processes for control forms, and to draft a dedicated recall procedure. Furthermore, they agreed to enhance complaint handling procedures to ensure proper investigation closure and customer notification, and to improve spectrophotometer calibration documentation with better record-keeping and quality oversight.