FDA 483 - Valley Biosystems - October 08, 2021

Valley Biosystems received a Form 483 citing 10 observations related to Good Laboratory Practice (GLP) deficiencies. Key issues include the study director's lack of overall responsibility and protocol adherence, inadequate data recording and retention, and failures in quality assurance, training, and equipment calibration. The report highlights significant concerns regarding data integrity and the proper conduct of nonclinical laboratory studies.