FDA 483 - Agricultural Technology Research Institute (ATRI) - April 27, 2026

The FDA issued a Form 483 to Biosafety Testing Laboratory in Agricultural Technology Research Institute (ATRI) following an inspection of their testing facility in Jiannan Township, Miaoli County, Taiwan. Observations included a lack of scientific data to support long-term frozen storage of test materials, inadequate audit procedures for digital microscopy images leading to unreliable data, and scientifically unjustified reanalysis of assay results without proper quality unit approval or documentation. These issues indicate significant concerns regarding the integrity and reliability of their laboratory controls and data management practices.