FDA 483 - Alturas Analytics, Inc - May 05, 2020

Alturas Analytics, Inc. in Moscow, ID, a nonclinical laboratory, was cited for significant deficiencies during an FDA inspection from April 14 to May 5, 2020. The observations highlight systemic failures in quality assurance, data integrity, record keeping, and adherence to standard operating procedures. These issues collectively indicate a lack of control over the reliability and accuracy of nonclinical laboratory study data.