FDA 483 - Smart World LLC - June 03, 2025

Smart World LLC dba Steri-Tek, a contract sterilizer in Fremont, CA, was cited for significant quality system and facility maintenance deficiencies during an FDA inspection. Observations included a lack of written procedures for the quality control unit, such as defining roles and responsibilities and handling recalls, leading to product release without proper Quality approval. Additionally, the facility's buildings were not maintained in good repair, with issues like an unsealed receiving door and pest control bait boxes surrounded by debris.